臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 11, 2024
Last modified on	Oct. 04, 2024
Trial ID	jRCT2051240123

Scientific Title	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
Public Title	A PHASE I STUDY OF BRY10 IN HEALTHY MALE ADULTS

Contact for Scientific Queries	Name	Kai Megumi
	Affiliation	National University Corporation Oita University Faculty of Medicine
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo
	Telephone	+81-120189706
	E-mail	clinical-trials@chugai-pharm.co.jp
Contact for Public Queries	Name	Clinical trials information
	Affiliation	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo
	Telephone	+81-120189706
	E-mail	clinical-trials@chugai-pharm.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 24, 2024
Actual date of first enrollment		Sept. 24, 2024
Target sample size		72
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- 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.
	Exclusion Criteria	- 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.
	Age Minimum	18age old over
	Age Maximum	44age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy Volunteers
Intervention(s)		BRY10: SC injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		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.)
Secondary Outcome(s)		phamacokinetics, other - Immunogenicity - Effct of Ethinic difference on pharmacokinetics

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Aug. 30, 2024

Plan to share IPD	Yes
Plan description	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).

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 04, 2024	(this page)	Changes
1	Sept. 11, 2024	Detail

List of change history