A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

Study identifier:D5290C00001

ClinicalTrials.gov identifier:NCT02114268

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

Medical condition

Respiratory Syncytial Virus Infections

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI8897 Intravenous, Placebo, MEDI8897 Intramuscular

Sex

All

Actual Enrollment

342

Study type

Interventional

Age

18 Years - 49 Years

Date

Study Start Date: 01 Apr 2014

Primary Completion Date: 01 Jun 2015

Study Completion Date: 01 Jun 2015

Study design

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

Verification:

Verified 01 Oct 2016 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Overland Park, KS, United States

Arms	Assigned Interventions
Experimental: MEDI8897 300 milligram (mg) Intravenous (IV) Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.	Drug: MEDI8897 Intravenous Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
Experimental: MEDI8897 1000 mg IV Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.	Drug: MEDI8897 Intravenous Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
Experimental: MEDI8897 3000 mg IV Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.	Drug: MEDI8897 Intravenous Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
Experimental: MEDI8897 100 mg Intramuscular (IM) Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.	Drug: MEDI8897 Intramuscular Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
Experimental: MEDI8897 300 mg IM Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.	Drug: MEDI8897 Intramuscular Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
Placebo Comparator: Placebo Participants received placebo on Day 1.	Drug: Placebo Participants received placebo on Day 1.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study.

Reporting Groups

	Description
Placebo	Participants received placebo on Day 1.
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Participant Flow: Overall Study

	Placebo	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
STARTED	34	6	6	6	6	78
COMPLETED	28	5	5	6	6	75
NOT COMPLETED	6	1	1	0	0	3
Lost to Follow-up	4	1	1	0	0	2
Withdrawal by Subject	1	0	0	0	0	1
Withdrawn by site due to noncompliance	1	0	0	0	0	0

Baseline Characteristics

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

The As-treated Population included participants who receive any study investigational product.

Reporting Groups

	Description
Placebo	Participants received placebo on Day 1.
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Baseline Measures

	Placebo	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)	Total
Number of Participants [units: Participants]	34	6	6	6	6	78	136
Age Continuous [units: Years] Mean ± Standard Deviation	29.2 ± 8.6	34.5 ± 8.6	34.3 ± 5.6	33.5 ± 6.7	30.7 ± 7.8	30.3 ± 7.9	30.5 ± 8.0
Gender, Male/Female [units: Participants]
Male	15	2	4	3	0	39	63
Female	19	4	2	3	6	39	73

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 start of study drug administration up to Day 391 (Day 361 +/- 30 days) ]

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 (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Time Frame	From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
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.
The As-treated population included participants who receive any study investigational product.

Reporting Groups

	Description
Placebo	Participants received placebo on Day 1.
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	Placebo	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	34	6	6	6	6	78
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [units: participants]
TEAEs	21	3	3	5	4	48
TESAEs	0	0	0	0	0	2

No statistical analysis provided for Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

2. Secondary Outcome Measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 [ Time Frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Measure Description	The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time Frame	Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
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 parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.

Reporting Groups

	Description
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	6	6	6	6	78
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 [units: Day] Mean (Standard Deviation)	0.078 (172)	0.059 (0)	0.209 (62.7)	5.46 (71.4)	9.42 (78.4)

No statistical analysis provided for Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897

3. Secondary Outcome Measure: Maximum Observed Serum Concentration (Cmax) for MEDI8897 [ Time Frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Maximum Observed Serum Concentration (Cmax) for MEDI8897
Measure Description	The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time Frame	Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
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 parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.

Reporting Groups

	Description
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	6	6	6	6	78
Maximum Observed Serum Concentration (Cmax) for MEDI8897 [units: microgram per milliliter (mcg/ml)] Mean (Standard Deviation)	96.98 (21.9)	333.80 (22.4)	1163.32 (23.8)	20.40 (29.4)	47.48 (26.2)

No statistical analysis provided for Maximum Observed Serum Concentration (Cmax) for MEDI8897

4. Secondary Outcome Measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 [ Time Frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897
Measure Description	The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time Frame	Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
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 parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.

Reporting Groups

	Description
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	5	5	5	5	75
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 [units: Day*microgram per milliliter] Mean (Standard Deviation)	6714.75 (21.7)	25320.68 (17)	63580.33 (10.4)	2249.11 (17.9)	5193.73 (32.1)

No statistical analysis provided for Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897

5. Secondary Outcome Measure: Terminal Phase Elimination Half Life (t1/2) for MEDI8897 [ Time Frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Terminal Phase Elimination Half Life (t1/2) for MEDI8897
Measure Description	The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time Frame	Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
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 parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.

Reporting Groups

	Description
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	5	5	5	5	75
Terminal Phase Elimination Half Life (t1/2) for MEDI8897 [units: Day] Mean (Standard Deviation)	116.52 (19.6)	92.0 (12.6)	89.81 (18.2)	102.61 (11.3)	85.29 (30.8)

No statistical analysis provided for Terminal Phase Elimination Half Life (t1/2) for MEDI8897

6. Secondary Outcome Measure: Systemic Clearance (CL) for MEDI8897 [ Time Frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Systemic Clearance (CL) for MEDI8897
Measure Description	Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time Frame	Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
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 parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.

Reporting Groups

	Description
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	5	5	5	5	75
Systemic Clearance (CL) for MEDI8897 [units: ml per day] Mean (Standard Deviation)	46.05 (17.3)	40.33 (15.4)	47.60 (10.6)	45.46 (15.4)	64.60 (37.7)

No statistical analysis provided for Systemic Clearance (CL) for MEDI8897

7. Secondary Outcome Measure: Volume of Distribution (Vz) for MEDI8897 [ Time Frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Volume of Distribution (Vz) for MEDI8897
Measure Description	The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time Frame	Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
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 parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.

Reporting Groups

	Description
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	5	5	5	5	75
Volume of Distribution (Vz) for MEDI8897 [units: milliliter (ml)] Mean (Standard Deviation)	7694.15 (24.8)	5426.89 (26.7)	6137.69 (18.5)	6808.78 (24.5)	7455.90 (34.0)

No statistical analysis provided for Volume of Distribution (Vz) for MEDI8897

8. Secondary Outcome Measure: Number of Participants With Positive Anti-Drug Antibody (ADA) [ Time Frame: Predose and Day 15, 31, 91, 181, 271 and 361 ]

Measure Type	Secondary
Measure Name	Number of Participants With Positive Anti-Drug Antibody (ADA)
Measure Description	Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.
Time Frame	Predose and Day 15, 31, 91, 181, 271 and 361
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 As-treated Population included participants who receive any study investigational product.

Reporting Groups

	Description
Placebo	Participants received placebo on Day 1.
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Measured Values

	Placebo	MEDI8897 300 milligram (mg) Intravenous (IV)	MEDI8897 1000 milligram (mg) Intravenous (IV)	MEDI8897 3000 milligram (mg) Intravenous (IV)	MEDI8897 100 milligram (mg) Intramuscular (IM)	MEDI8897 300 milligram (mg) Intramuscular (IM)
Number of Participants Analyzed [units:participants]	34	6	6	6	6	78
Number of Participants With Positive Anti-Drug Antibody (ADA) [units: participants]
Predose	3	0	0	0	0	5
At Any Time Postdose	5	0	1	0	0	13

No statistical analysis provided for Number of Participants With Positive Anti-Drug Antibody (ADA)

Serious Adverse Events

Time Frame	From Screening to Postdose Follow-up (up to 391 Days)
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received placebo on Day 1.
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Serious Adverse Events

Placebo

MEDI8897 300 milligram (mg) Intravenous (IV)

MEDI8897 1000 milligram (mg) Intravenous (IV)

MEDI8897 3000 milligram (mg) Intravenous (IV)

MEDI8897 100 milligram (mg) Intramuscular (IM)

MEDI8897 300 milligram (mg) Intramuscular (IM)

Total, serious adverse events

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

2/78 (2.56%)

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Gun shot wound¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 18.0

Other Adverse Events

Time Frame	From Screening to Postdose Follow-up (up to 391 Days)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Placebo	Participants received placebo on Day 1.
MEDI8897 300 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 milligram (mg) Intravenous (IV)	Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 milligram (mg) Intramuscular (IM)	Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Other Adverse Events

Placebo

MEDI8897 300 milligram (mg) Intravenous (IV)

MEDI8897 1000 milligram (mg) Intravenous (IV)

MEDI8897 3000 milligram (mg) Intravenous (IV)

MEDI8897 100 milligram (mg) Intramuscular (IM)

MEDI8897 300 milligram (mg) Intramuscular (IM)

Total, other (not including serious) adverse events

# participants affected / at risk

21/34 (61.76%)

3/6 (50.00%)

5/6 (83.33%)

4/6 (66.67%)

48/78 (61.54%)

Eye disorders

Blepharospasm¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Eye disorders

Lacrimation increased¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Eye disorders

Vision blurred¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

3/78 (3.85%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/34 (2.94%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Gastrointestinal disorders

Food poisoning¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

2/34 (5.88%)

0/6 (0.00%)

2/6 (33.33%)

0/6 (0.00%)

3/78 (3.85%)

# events

Gastrointestinal disorders

Salivary gland pain¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

5/78 (6.41%)

# events

General disorders and administration site conditions

Cyst¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

General disorders and administration site conditions

Drug intolerance¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

General disorders and administration site conditions

Infusion site erythema¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

General disorders and administration site conditions

Injection site pain¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

1/78 (1.28%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Immune system disorders

Seasonal allergy¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Infections and infestations

Acarodermatitis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Bacterial infection¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Bacterial vaginosis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

2/78 (2.56%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Candida infection¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Infections and infestations

Chlamydial infection¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Conjunctivitis viral¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Herpes simplex¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Injection site infection¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

2/78 (2.56%)

# events

Infections and infestations

Pharyngitis streptococcal¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Staphylococcal infection¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Infections and infestations

Tooth abscess¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

3/34 (8.82%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

16/78 (20.51%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

2/6 (33.33%)

4/78 (5.13%)

# events

Infections and infestations

Viral upper respiratory tract infection¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Injury, poisoning and procedural complications

Arthropod bite¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Bone contusion¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Comminuted fracture¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Eye injury¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Foot fracture¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Laceration¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Muscle strain¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Post concussion syndrome¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Injury, poisoning and procedural complications

Rib fracture¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Sunburn¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Injury, poisoning and procedural complications

Tooth fracture¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Investigations

Blood bilirubin increased¹,^†

# participants affected / at risk

0/34 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Investigations

Blood creatine phosphokinase increased¹,^†

# participants affected / at risk

2/34 (5.88%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Metabolism and nutrition disorders

Type 2 diabetes mellitus¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

3/78 (3.85%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

4/78 (5.13%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Musculoskeletal and connective tissue disorders

Tendonitis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

6/34 (17.65%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

7/78 (8.97%)

# events

Nervous system disorders

Neuropathy peripheral¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Nervous system disorders

Paraesthesia¹,^†

# participants affected / at risk

2/34 (5.88%)

0/6 (0.00%)

1/78 (1.28%)

# events

Nervous system disorders

Presyncope¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/78 (0.00%)

# events

Nervous system disorders

Somnolence¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Psychiatric disorders

Post-traumatic stress disorder¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Reproductive system and breast disorders

Menorrhagia¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Reproductive system and breast disorders

Polycystic ovaries¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

4/78 (5.13%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

1/78 (1.28%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinitis allergic¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/78 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Sinus congestion¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Respiratory, thoracic and mediastinal disorders

Tachypnoea¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/78 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/78 (1.28%)

# events

Skin and subcutaneous tissue disorders

Dermatitis allergic¹,^†

# participants affected / at risk

1/34 (2.94%)

0/6 (0.00%)

0/78 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis contact¹,^†

# participants affected / at risk

0/34 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

3/78 (3.85%)

# events

Skin and subcutaneous tissue disorders

Eczema¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Skin and subcutaneous tissue disorders

Hyperhidrosis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

Skin and subcutaneous tissue disorders

Hyperkeratosis¹,^†

# participants affected / at risk

0/34 (0.00%)

0/6 (0.00%)

1/78 (1.28%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 18.0

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 ongoing 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
Physical examination parameters of participants were not evaluated.

Results Point of Contact

Name/Title:	M. Pamela Griffin, MD, Senior Director
Organization:	MedImmune, LLC
Phone	301-398-0000
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

M. Pamela Griffin

MedImmune, LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Trial Results Summaries