A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7442 in Healthy Japanese Participants

Completed

• Conditions: COVID-19

• Registration Number: jRCT2071200111
• Lead Sponsor: Astrazeneca K.K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study Start: 2021-03-16
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.

2. Negative results from both SARS-CoV-2 qRT-PCR and serology tests

3. Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators

Exclusion Criteria

1. Fever above 37.5 degrees Celsius by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.

2. History of infection with SARS or MERS

3. Any drug therapy within 7 days prior to Day 1

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
adverse event	To evaluate the safety and tolerability of AZD7442 administered IV or IM to healthy participants 18 to 55 years of age.	adverse events, concomitant therapy, safety laboratory parameters (haematology, clinical chemistry, coagulation, and urinalysis); 12-lead ECG; vital signs, and physical examination.
Pharmacokinetics	To evaluate Pharmacokinetics of AZD8895 and AZD1061 after single IV/IM administration of AZD7442.	After IV infusion: Ceoi, Cmax, Tmax, t1/2 z, AUClast, AUCinf, Vss, Vz and CL. After IM injection: Cmax, Tmax, t1/2 z, AUClast, AUCinf, extravascular systemic clearance (CL/F), bioavailability (F) and extravascular terminal phase volume of distribution (Vz/F).