臨床研究等提出・公開システム

A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF BRY10 IN HEALTHY VOLUNTEERS

A PHASE I STUDY OF BRY10 IN HEALTHY MALE ADULTS

Awaya Norihiro

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Sept. 24, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Signed ICF.
- Able to comply with the study protocol, in the investigators judgment.
- Have a body mass index (body weight [kg]/height [m]^2) >=18.5 kg/m^2 or <25.0 kg/m^2(Asian Cohorts) or >=18.5 kg/m^2 or <30.0 kg/m^2 (non-Asian Cohorts), and body weight >=50 kg at screening.
- Have no findings indicating an active or chronic disease, based on detailed hearing of medical and surgery histories and the results of physical examination, vital sign measurements, ECG, and laboratory tests.

- Clinically significant abnormal ECG at screening.
- Current cardiovascular, renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrine, metabolic, or pulmonary disorder or a history of any of these disorders and impaired renal, hepatic, or cardiopulmonary function.

Male

Healthy Volunteers

BRY10: SC injection

safety, phamacokinetics, other
- Frequency, severity and relationship of adverse events including serious adverse events (SAE) to BRY10
- Laboratory values, vital signs and ECGs
- Plasma concentrations and pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, etc.)

phamacokinetics, other
- Immunogenicity
- Effct of Ethinic difference on pharmacokinetics

+81-6-6395-9000

Aug. 30, 2024

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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