Safety and tolerability of MEDI9314 as single ascending dose in healthy subjects

Study identifier:D4361C00002

ClinicalTrials.gov identifier:NCT02669667

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects

Medical condition

Safety, Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI9314, placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 18 Feb 2016

Primary Completion Date: 17 Nov 2016

Study Completion Date: 12 Jun 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 May 2019 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Written informed consent.
2. Age 18 through 50 years at the time of screening.
3. Female subjects must be of non-childbearing potential.
4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.
5. Body mass index of 19.0 through 32.0 kg/m2 at screening.
6. No clinically significant abnormality on the basis of medical/medication history or physical examination.
7. Negative drugs of abuse (DOA).
8. Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
9. For the Japanese Cohort, both of the subject’s parents and both sets of grandparents must be Japanese.

Exclusion Criteria

1.Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
2.Concurrent enrollment in another clinical study involving any treatment.
3.Individuals who are legally institutionalized.
4.Receipt of > 2 marketed or investigational biologic agents.
5.Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.
6.Receipt of any investigational non biologic agent within 3 months or 5 half lives prior to screening, whichever is longer.
7.Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of the investigator and medical monitor the
medication will not interfere with the study procedures or compromise subject safety.
8.Known history of allergy or reaction to any component of the investigational product formulation.
9.History of anaphylaxis following any biologic therapy.
10.Any clinically relevant abnormal findings in physical examination ECG, vital signs, and laboratory parameters.
11.Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).
12.Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at screening.
13.Receipt of live attenuated vaccines 30 days prior to the date of screening.
14.Where donation of blood or blood products was in excess of 500 mL within an 8-week period in the 3 months prior to screening.

Location

Research Site

Harrow, United Kingdom, HA1 3UJ

Location

Research Site

Glendale, CA, United States, 91206

Arms	Assigned Interventions
Experimental: Cohort 1 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 2 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 3 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 4 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Japanese Cohort single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo
Experimental: Cohort 5 single dose of MEDI9314 or placebo	Drug: MEDI9314 single dose of MEDI9314 Drug: placebo single dose of placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted from 18Feb2016 to 12Jun2017 in United States and United Kingdom.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 124 participants were enrolled in the study; of which 80 participants were screen failures. Forty-four participants were randomized to MEDI9314 or placebo" in 7 treatment groups.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Participant Flow: Overall Study

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
STARTED	12	4	4	6	6	6	6
COMPLETED	12	4	4	6	6	5	6
NOT COMPLETED	0	0	0	0	0	1	0
Lost to Follow-up	0	0	0	0	0	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Baseline Measures

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6	Total
Number of Participants [units: Participants]	12	4	4	6	6	6	6	44
Age Continuous [units: Years] Mean ± Standard Deviation	33.8 ± 10.2	32.0 ± 12.1	28.0 ± 5.1	32.0 ± 8.6	35.0 ± 5.3	31.2 ± 8.2	36.0 ± 10.5	33.0 ± 8.7
Sex: Female, Male [units: ]
Male	12	4	4	6	6	6	6	44
Female	0	0	0	0	0	0	0	0
Race (NIH/OMB) [units: ]
American Indian or Alaska Native	0	0	0	0	0	0	0	0
Asian	3	1	0	0	6	1	0	11
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Black or African American	1	2	0	0	0	0	1	4
White	8	1	4	6	0	4	5	28
More than one race	0	0	0	0	0	1	0	1
Unknown or Not Reported	0	0	0	0	0	0	0	0
Ethnicity (NIH/OMB) [units: ]
Hispanic or Latino	0	0	0	0	0	1	1	2
Not Hispanic or Latino	12	4	4	6	6	5	5	42
Unknown or Not Reported	0	0	0	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From the start of study drug administration upto Day 240 ]

Measure Type	Primary
Measure Name	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measure Description	An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
Time Frame	From the start of study drug administration upto Day 240
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [units: Participants]
TEAEs	8	4	2	5	4	5	5
TESAEs	0	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

2. Primary Outcome Measure: Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs [ Time Frame: From the start of study drug administration upto Day 240 ]

Measure Type	Primary
Measure Name	Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs
Measure Description	TEAEs observed in participants with clinically significant ECG abnormalities were reported.
Time Frame	From the start of study drug administration upto Day 240
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs [units: Participants]	0	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs

3. Primary Outcome Measure: Number of Participants With Vital Signs Abnormalities Reported as TEAEs [ Time Frame: From the start of study drug administration upto Day 240 ]

Measure Type	Primary
Measure Name	Number of Participants With Vital Signs Abnormalities Reported as TEAEs
Measure Description	Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.
Time Frame	From the start of study drug administration upto Day 240
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants With Vital Signs Abnormalities Reported as TEAEs [units: Participants]	0	0	0	1	0	0	0

No statistical analysis provided for Number of Participants With Vital Signs Abnormalities Reported as TEAEs

4. Primary Outcome Measure: Number of Participants With Physical Examination Abnormalities Reported as TEAEs [ Time Frame: From the start of study drug administration upto Day 240 ]

Measure Type	Primary
Measure Name	Number of Participants With Physical Examination Abnormalities Reported as TEAEs
Measure Description	Adverse events observed in participants with clinically significant physical abnormalities were assessed.
Time Frame	From the start of study drug administration upto Day 240
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants With Physical Examination Abnormalities Reported as TEAEs [units: Participants]	0	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Physical Examination Abnormalities Reported as TEAEs

5. Primary Outcome Measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs [ Time Frame: From the start of study drug administration upto Day 240 ]

Measure Type	Primary
Measure Name	Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Measure Description	An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time Frame	From the start of study drug administration upto Day 240
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs [units: Participants]
Liver function test increased	0	0	0	0	1	0	0
Transaminases increased	1	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

6. Primary Outcome Measure: Number of Participants with TEAEs related to Injection Site Reactions [ Time Frame: From the start of study drug administration upto Day 240 ]

Measure Type	Primary
Measure Name	Number of Participants with TEAEs related to Injection Site Reactions
Measure Description	Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.
Time Frame	From the start of study drug administration upto Day 240
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants with TEAEs related to Injection Site Reactions [units: Participants]
Infusion site bruising	0	0	0	0	0	1	0
Infusion site erythema	0	0	0	0	0	1	0
Infusion site pruritus	0	0	0	0	0	1	0
Injection site bruising	1	0	0	0	0	0	0
Injection site erythema	2	4	1	5	0	0	0
Injection site haemorrhage	1	0	1	0	0	0	0
Injection site induration	0	0	0	0	4	0	0
Injection site pain	0	0	0	1	0	0	0
Injection site pruritus	0	0	1	0	0	0	0
Injection site warmth	1	0	1	0	0	0	0

No statistical analysis provided for Number of Participants with TEAEs related to Injection Site Reactions

7. Secondary Outcome Measure: Area under the serum drug concentration versus time curves from zero to infinity (AUC 0-inf) of MEDI9314 [ Time Frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 ]

Measure Type	Secondary
Measure Name	Area under the serum drug concentration versus time curves from zero to infinity (AUC 0-inf) of MEDI9314
Measure Description	The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.
Time Frame	Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic (PK) population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	4	4	6	6	6	6
Area under the serum drug concentration versus time curves from zero to infinity (AUC 0-inf) of MEDI9314 [units: µg*d/mL] Mean (Standard Deviation)	3.01 (NA)^[1]	68.8 (47.3)	179 (105)	264 (159)	668 (132)	1440 (126)

No statistical analysis provided for Area under the serum drug concentration versus time curves from zero to infinity (AUC 0-inf) of MEDI9314

8. Secondary Outcome Measure: Area under the serum drug concentration versus time curve, to last quantifiable time point (AUClast) [ Time Frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 ]

Measure Type	Secondary
Measure Name	Area under the serum drug concentration versus time curve, to last quantifiable time point (AUClast)
Measure Description	The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.
Time Frame	Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	4	4	6	6	6	6
Area under the serum drug concentration versus time curve, to last quantifiable time point (AUClast) [units: μg*d/mL] Mean (Standard Deviation)	2.94 (NA)^[1]	68.6 (47.3)	178 (105)	264 (159)	667 (132)	1439 (126)

No statistical analysis provided for Area under the serum drug concentration versus time curve, to last quantifiable time point (AUClast)

9. Secondary Outcome Measure: Maximum observed serum drug concentration (Cmax) of MEDI9314 [ Time Frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 ]

Measure Type	Secondary
Measure Name	Maximum observed serum drug concentration (Cmax) of MEDI9314
Measure Description	The maximum observed serum drug concentration of MEDI9314.
Time Frame	Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.

Reporting Groups

	Description
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	4	4	6	6	6	6
Maximum observed serum drug concentration (Cmax) of MEDI9314 [units: µg/mL] Mean (Standard Deviation)	0.425 (0.367)	5.44 (2.77)	10.4 (5.63)	14.1 (8.87)	79.0 (14.8)	108 (9.99)

No statistical analysis provided for Maximum observed serum drug concentration (Cmax) of MEDI9314

10. Secondary Outcome Measure: Time to maximum observed serum drug concentration (tmax) of MEDI9314 [ Time Frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 ]

Measure Type	Secondary
Measure Name	Time to maximum observed serum drug concentration (tmax) of MEDI9314
Measure Description	The time to maximum observed serum drug concentration of MEDI9314.
Time Frame	Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.

Reporting Groups

	Description
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	4	4	6	6	6	6
Time to maximum observed serum drug concentration (tmax) of MEDI9314 [units: Day] Median (Full Range)	4.00 (3.99 to 4.00)	8.07 (2.99 to 9.03)	5.52 (3.00 to 9.13)	5.51 (3.99 to 9.08)	0.04 (0.04 to 0.04)	0.04 (0.04 to 0.04)

No statistical analysis provided for Time to maximum observed serum drug concentration (tmax) of MEDI9314

11. Secondary Outcome Measure: Terminal phase elimination half-life (t1/2) of MEDI9314 [ Time Frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 ]

Measure Type	Secondary
Measure Name	Terminal phase elimination half-life (t1/2) of MEDI9314
Measure Description	Terminal phase elimination half-life of MEDI9314
Time Frame	Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	4	4	6	6	6	6
Terminal phase elimination half-life (t1/2) of MEDI9314 [units: Day] Mean (Standard Deviation)	1.74 (NA)^[1]	3.55 (0.685)	4.72 (0.998)	5.03 (1.13)	7.31 (1.29)	8.95 (1.14)

No statistical analysis provided for Terminal phase elimination half-life (t1/2) of MEDI9314

12. Secondary Outcome Measure: Serum concentrations of MEDI9314 [ Time Frame: Baseline (Day 1 [predose]) and Day 240 ]

Measure Type	Secondary
Measure Name	Serum concentrations of MEDI9314
Measure Description	Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.
Time Frame	Baseline (Day 1 [predose]) and Day 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	4	4	6	6	6	6
Serum concentrations of MEDI9314 [units: μg/mL] Mean (Standard Deviation)
Baseline	21.495 (14.790)	9.770 (0.000)	22.577 (31.370)	9.770 (0.000)	9.770 (0.000)	9.770 (0.000)
Day 240	23.432 (20.738)	9.770 (0.000)	9.770 (0.000)	13.167 (8.320)	9.770 (0.000)	14.573 (11.766)

No statistical analysis provided for Serum concentrations of MEDI9314

13. Secondary Outcome Measure: Number of Participants Positive for Anti-Drug Antibodies to MEDI9314 [ Time Frame: Baseline (Day 1 [predose]) and Day 240 ]

Measure Type	Secondary
Measure Name	Number of Participants Positive for Anti-Drug Antibodies to MEDI9314
Measure Description	Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.
Time Frame	Baseline (Day 1 [predose]) and Day 240
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Measured Values

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Number of Participants Analyzed [units:participants]	12	4	4	6	6	6	6
Number of Participants Positive for Anti-Drug Antibodies to MEDI9314 [units: Participants]
Baseline ADA positive	0	0	0	0	0	1	0
Day 240- ADA positive	0	0	0	2	1	1	1

No statistical analysis provided for Number of Participants Positive for Anti-Drug Antibodies to MEDI9314

Serious Adverse Events

Time Frame	From the start of study drug administration upto Day 240
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Serious Adverse Events

	Placebo	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Total, serious adverse events
# participants affected / at risk	0/12 (0.00%)	0/4 (0.00%)	0/4 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)

Other Adverse Events

Time Frame	From the start of study drug administration upto Day 240
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Placebo	Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
Cohort 1	Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
Cohort 2	Participants received a single SC injection of MEDI9314 150 mg on Day 1.
Cohort 3	Participants received a single SC injection of MEDI9314 300 mg on Day 1.
Cohort 4	Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
Cohort 5	Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
Cohort 6	Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.

Other Adverse Events

Placebo

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Total, other (not including serious) adverse events

# participants affected / at risk

8/12 (66.67%)

4/4 (100.00%)

2/4 (50.00%)

5/6 (83.33%)

4/6 (66.67%)

5/6 (83.33%)

Ear and labyrinth disorders

Ear pain¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Gastrointestinal disorders

Dry mouth¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Gastrointestinal disorders

Toothache¹,^†

# participants affected / at risk

1/12 (8.33%)

1/4 (25.00%)

0/4 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Infusion site bruising¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Infusion site erythema¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Infusion site pruritus¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site bruising¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site erythema¹,^†

# participants affected / at risk

2/12 (16.67%)

4/4 (100.00%)

1/4 (25.00%)

5/6 (83.33%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site haemorrhage¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site induration¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

4/6 (66.67%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site pain¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site pruritus¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Injection site warmth¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Immune system disorders

Seasonal allergy¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Infections and infestations

Hordeolum¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

# events

Infections and infestations

Skin bacterial infection¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Infections and infestations

Viral upper respiratory tract infection¹,^†

# participants affected / at risk

3/12 (25.00%)

2/4 (50.00%)

0/4 (0.00%)

2/6 (33.33%)

0/6 (0.00%)

3/6 (50.00%)

# events

Injury, poisoning and procedural complications

Hand fracture¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Joint dislocation¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Scratch¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Liver function test increased¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Transaminases increased¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

0/6 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

1/12 (8.33%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Myalgia intercostal¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

1/12 (8.33%)

1/4 (25.00%)

0/4 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Skin and subcutaneous tissue disorders

Dermatitis contact¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Skin and subcutaneous tissue disorders

Miliaria¹,^†

# participants affected / at risk

0/12 (0.00%)

0/4 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

0/12 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/6 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 20.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Rene van der Merwe
Organization:	MedImmune
Phone	+44 (0)1223 898263
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Muna Albayaty

PAREXEL

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Trial Results Summaries