A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7442 in Healthy Japanese Participants
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2071200111
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
The safety and tolerability data over the study period (361 days) of AZD7442 300 mg IM, 600 mg IM, 300 mg IV and 1000 mg IV administration did not raise any safety concerns in healthy Japanese participants. - Overall, the PK analysis supports that the PK of AZD8895 and AZD1061 were similar and that these 2 antibodies followed linear kinetics. - ADA incidence was 6.7% (2 out of 30 participants), with no effect on the serum concentration of either AZD8895 or AZD1061.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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
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
- Not specified
- Primary Outcome Measures
Name Time Method 1. adverse event<br>adverse events, concomitant therapy, safety laboratory parameters (haematology, clinical chemistry, coagulation, and urinalysis); 12-lead ECG; vital signs, and physical examination.<br>[Time Frame: To evaluate the safety and tolerability of AZD7442 administered IV or IM to healthy participants 18 to 55 years of age.]<br><br>2. Pharmacokinetics<br>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).<br>[Time Frame: To evaluate Pharmacokinetics of AZD8895 and AZD1061 after single IV/IM administration of AZD7442.]
- Secondary Outcome Measures
Name Time Method