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

Phase 1

• Conditions: coronavirus disease 2019(COVID-19)

• Registration Number: JPRN-jRCT2071200117
• Lead Sponsor: anki Toshihiro

Brief Summary

It was confirmed that single IV administration of 2400 mg, 8000 mg and single SC administration of 1200 mg of the study drug for Japanese adult volunteers were generally safe and tolerable. In the single IV dose cohort and the single SC dose cohort, the mean serum casirivimab and imdevimab concentrations remained above the therapeutic target drug level of 20 mg/L up to 28 days after administration in any dose groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-29
• Study Completion: 2021-11-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion 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

Exclusion 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified