臨床研究等提出・公開システム

Date of registration	Mar. 24, 2026
Last modified on	June. 09, 2026
Trial ID	jRCT2071250147

Scientific Title	ONO-2416-01: A phase I placebo-controlled, double-blind, randomized, parallel-group study and a phase I uncontrolled, open-label study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of ONO-2416 in Japanese healthy adult male subjects
Public Title	ONO-2416-01: A phase I study to evaluate the safety, tolerability, and pharmacokinetics of ONO-2416 in Japanese healthy adult male subjects

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 13, 2026
Actual date of first enrollment		April. 17, 2026
Target sample size		86
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	- Japanese healthy adult male subjects - 18 to 45 years of age, inclusive, at the time of signing the informed consent form - BMI of >= 18.5 kg/m^2 and < 25.0 kg/m^2 at screening
	Exclusion Criteria	- 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. - Subjects with current or with a history of severe allergy to drugs or foods - 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		Healthy volunteers(The planned indication has not been determined.)
Intervention(s)		- Part A (Single-dose part): A single oral dose of ONO-2416 or placebo will be administered. - Part B (Multiple-dose part): Repeated oral doses of ONO-2416 or placebo will be administered. - Part C (Mass balance assessment part): A single oral dose of ONO-2416 will be administered. - Part D (Electroencephalography assessment part): A single oral dose of ONO-2416 will be administered.
Primary Outcome(s)		- Part A (Single-dose part): A single oral dose of ONO-2416 or placebo will be administered. - Part B (Multiple-dose part): Repeated oral doses of ONO-2416 or placebo will be administered. - Part C (Mass balance assessment part): A single oral dose of ONO-2416 will be administered. - Part D (Electroencephalography assessment part): A single oral dose of ONO-2416 will be administered.
Secondary Outcome(s)		Mass balance (Part C only), Electroencephalogram (Part D only)

Primary Sponsor	Ono Pharmaceutical Co.,LTD.

Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Mar. 26, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 09, 2026	(this page)	Changes
2	Mar. 31, 2026	Detail	Changes
1	Mar. 24, 2026	Detail

List of change history