NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071200117

Registered date:29/03/2021

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedcoronavirus disease 2019(COVID-19)
Date of first enrollment31/03/2021
Target sample size22
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeSafety, 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 OutcomeOther - Incidence of Anti-Drug Antibodies (ADAs) to casirivimab and imdevimab

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 90age old
GenderBoth
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

Contact

Public contact
Name Clinical trials information
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120189706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co., Ltd.
Scientific contact
Name Toshihiro Nanki
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Toho University Medical Center Omori Hospital