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

A PHASE I, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS OF CASIRIVIMAB AND IMDEVIMAB IN JAPANESE ADULT VOLUNTEERS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200117

Enrollment

Registered

2021-03-29

Start date

2021-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronavirus disease 2019(COVID-19)

Interventions

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(Ge

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Other - Incidence of Anti-Drug Antibodies (ADAs) to casirivimab and imdevimab	—

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120189706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026