COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071200117

Clinical trials information

clinical-trials@chugai-pharm.co.jp

2021-03-29

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

- Absence of findings suggestive of active disease- For subjects with chronic diseases, maintaining stable state at least 6 months prior to screening- Willingness and ability to comply with the requirements of the study protocol- Consent to contraception

- Positive diagnostic test results for SARS-CoV-2 infection using samples collected within 72 hours prior to enrollment- A History of positive diagnostic tests for SARS-CoV-2 infection- Medically attended acute disease, systemic administration of antibiotics, or hospitalization at least one night for any reason within 30 days prior to screening- One or more clinically significant abnormal laboratory results at screening- A severe allergy, anaphylactic reaction or hypersensitivity to chimeric, human, humanized antibodies or fusion protein or drug (including additives)

3

Nanki Toshihiro

20

90

Japan

Healthy volunteers

N/A

22

Safety; PhamacokineticsSafety and Tolerability Endpoints- Adverse events that occurred after the initial dose of the study drug; including serious adverse events (SAEs)- Vital signs- Physical Findings- Laboratory Findings- 12-lead electrocardiographyEvaluation items for PK- Concentrations and PK parameters of casirivimab and imdevimab in Serum

Phase 1

[{"arm_notes": "IV", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "SC", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]