A PHASE I STUDY OF CASIRIVIMAB AND IMDEVIMAB IN JAPANESE ADULT VOLUNTEERS

JRCT ID: jRCT2071200117

Registered date:29/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: coronavirus disease 2019(COVID-19)
• Date of first enrollment: 31/03/2021
• Target sample size: 22
• Study type: Interventional

Intervention(s)

IV Cohort : A single IV dose of Casirivimab(Genetical Recombination)1200mg and Imdevimab(Genetical Recombination)1200mg, a single IV dose of Casirivimab(Genetical Recombination)4000mg and Imdevimab(Genetical Recombination)4000mg or a single IV dose of placebe
SC Cohort : A single SC dose of Casirivimab(Genetical Recombination)600mg and Imdevimab(Genetical Recombination)600mg or a single SC dose of placebo

Outcome(s)

Primary Outcome

Safety, Phamacokinetics
Safety 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 electrocardiography
Evaluation items for PK
- Concentrations and PK parameters of casirivimab and imdevimab in Serum

Secondary Outcome

Other
- Incidence of Anti-Drug Antibodies (ADAs) to casirivimab and imdevimab

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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)

Related Information

• Primary Sponsor: Nanki Toshihiro