臨床研究等提出・公開システム

Scientific Title	A PHASE I, RANDOMIZED, DOUBLE-BLIND ,PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS
Public Title	A PHASE I, TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS

Contact for Scientific Queries	Name	Kai Megumi
	Affiliation	Oita University Faculty of Medicine
	Address	1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo
	Telephone	+81-120-189-706
	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	+81-120-189-706
	E-mail	clinical-trials@chugai-pharm.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 24, 2022
Actual date of first enrollment		Oct. 24, 2022
Target sample size		40
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 - BMI at screening: (Body weight [kg]/height [m]2) =>18.5 to <25.0 - Absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination, vital signs, 12-lead ECG, and laboratory tests
	Exclusion Criteria	- Clinically significant ECG abnormalities at screening - known congenital arrhythmiarespiratory, circulatory, endocrine, hematological, gastrointestinal, immune, psychological/nervous system, renal, hepatic, or allergic disorder
	Age Minimum	18age old over
	Age Maximum	44age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy Volunteer
Intervention(s)		RAY121: RAY121 is administered as a intravenously or subcutaneously at the prescribed dose.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety Frequency, severity and causal reletionship of AE and SAE with RAY121 Changes in Lab value,Vital, and ECG parameters from Baseline
Secondary Outcome(s)		Phamacokinetics, Phamacodynamics

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	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	July. 29, 2022

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

List of change history