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

JRCT ID: jRCT2071200111

Registered date:10/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 16/03/2021
• Target sample size: 32
• Study type: Interventional

Intervention(s)

Approximately 40 participants will be randomized in a 6:2 ratio. Arm 1 (n=approximately 30) will receive AZD7442.Arm 2 (n=approximately 10) will receive saline placebo.
Cohort1: IM_ AZD 7442 300mg , Cohort2 IM_AZD7442600mg , Cohort3 IV_ AZD7442 300mg , Cohort4_IV AZD7442 1000mg

Outcome(s)

Primary Outcome

1. adverse event
adverse events, concomitant therapy, safety laboratory parameters (haematology, clinical chemistry, coagulation, and urinalysis); 12-lead ECG; vital signs, and physical examination.
[Time Frame: To evaluate the safety and tolerability of AZD7442 administered IV or IM to healthy participants 18 to 55 years of age.]

2. Pharmacokinetics
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).
[Time Frame: To evaluate Pharmacokinetics of AZD8895 and AZD1061 after single IV/IM administration of AZD7442.]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04896541