COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071200111

Kazushige Hibi

RD-clinical-information-Japan@astrazeneca.com

2021-03-10

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

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 tests3. Healthy by medical history, physical examination, and safety laboratorytests, 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 MERS3. Any drug therapy within 7 days prior to Day 1

2

Hibi Kazushige

18

55

Japan

Healthy volunteers

N/A

32

1. adverse eventadverse events; concomitant therapy; safety laboratory parameters (haematology; clinical chemistry; coagulation; andurinalysis); 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 55years of age.]2. PharmacokineticsAfter 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 volumeof distribution (Vz/F).[Time Frame: To evaluate Pharmacokinetics of AZD8895 and AZD1061 after single IV/IM administration of AZD7442.]

Phase 1

[{"arm_notes": "", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]