臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 11, 2024
Last modified on	Sept. 11, 2024
Trial ID	jRCT2071240056

Scientific Title	ONO-4915-01:ONO-4915 Phase I study A Phase I randomized, single-blind, parallel-group study in Japanese healthy adult males to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ONO-4915 given as a single continuous intravenous dose, a single subcutaneous dose, and repeated subcutaneous doses
Public Title	ONO-4915-01:ONO-4915 Phase I study A study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ONO-4915 in Japanese healthy adult males

Contact for Scientific Queries	Name	Hirashima Yoshinori
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Medical Information Center
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 11, 2024
Actual date of first enrollment
Target sample size		160
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Japanese healthy adult male subjects 2) Age at the time of informed consent: 18 to 45 3) BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2
	Exclusion Criteria	1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease. 2) Subjects with current or with a history of severe allergy to drugs or foods 3) Subjects with current or with a history of drug or alcohol abuse
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Auto immune disease
Intervention(s)		1) Single intravenous infusion part ONO-4915 or placebo will be administered as a single intravenous infusion. 2) Single subcutaneous injection part ONO-4915 or placebo will be administered as a single subcutaneous injection. 3) Repeated subcutaneous injection part ONO-4915 or placebo will be repeatedly administered as subcutaneous injections.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety, Pharmacokinetics
Secondary Outcome(s)		Pharmacodynamics,Immunogenicity

Primary Sponsor	Ono 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, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none