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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.

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Official Title

Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.

Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.

Participants received single IV dose of MEDI4920 10 mg infused on Day 1.

Participants received single IV dose of MEDI4920 30 mg infused on Day 1.

Participants received single IV dose of MEDI4920 100 mg infused on Day 1.

Participants received single IV dose of MEDI4920 300 mg infused on Day 1.

Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.

Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.

Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920

Phase 1 Single-ascending Dose Study to evaluate Safety and Tolerability of MEDI4920 in Healthy Adults

NCT ID

Therapeutic Area

Research Site

A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults

An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.

Age Continuous

Gender, Male/Female

As-treated population included all participants who received any study drug. Two participants were erroneously randomized to MEDI4920 10 mg group due to the IXRS system not being opened for start of MEDI4920 30 mg group. However, these participants received the 30 mg dose.

TEAEs

TESAEs

As-treated Population: All participants who received any study drug were included in this population

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Maximum Observed Plasma Concentration (Cmax) of MEDI4920

The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920

The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920

The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI4920 dose. The AUC (0-infinity)/D was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920

The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Terminal Elimination Half Life
(t1/2) of MEDI4920

The systemic clearance (CL) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Systemic Clearance (CL) of MEDI4920

The volume of distribution at steady-state (Vss) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Volume of Distribution at Steady-state (Vss) of MEDI4920

The volume of distribution based on terminal phase (Vz) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920

Baseline ADA positive

Post-baseline ADA positive

Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented.

Percentage of Participants Positive for Anti-drug Antibodies (ADA)

The T-cell dependent antibody response (TDAR) assay measures the immune response (ie, antibody production) to an introduced antigen, keyhole limpet hemocyanin (KLH). The KLH is a potent immunostimulating protein with an extensive history of safe and effective use in vaccine development and immunological research. TDAR was evaluated by measuring anti-KLH IgG titers at a time point consistent with the expected timing for antibody responses following immunization. The primary time point for the analysis of the TDAR to KLH was Day 43. The data was presented for geometric mean ratio (MEDI4920/placebo) estimated from the dose response model.

T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G  (Anti-KLH IgG) Concentration

Overall Study

A total of 259 participants were screened of which 200 participants were considered screen failures and the remaining 59 participants were randomized. Out of which, 56 participants were treated

Arms	Assigned Interventions
Placebo Comparator: Placebo Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	Other: Placebo Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Experimental: MEDI4920 3 mg Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	Biological/Vaccine: MEDI4920 3 mg Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
Experimental: MEDI4920 10 mg Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	Biological/Vaccine: MEDI4920 10 mg Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
Experimental: MEDI4920 30 mg Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	Biological/Vaccine: MEDI4920 30 mg Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
Experimental: MEDI4920 100 mg Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	Biological/Vaccine: MEDI4920 100 mg Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
Experimental: MEDI4920 300 mg Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	Biological/Vaccine: MEDI4920 300 mg Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
Experimental: MEDI4920 1000 mg Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	Biological/Vaccine: MEDI4920 1000 mg Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
Experimental: MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.	Biological/Vaccine: MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.

Phase 1 Single-ascending Dose Study to evaluate Safety and Tolerability of MEDI4920 in Healthy Adults

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact