臨床研究等提出・公開システム

Date of registration	July. 28, 2026
Last modified on	Sept. 01, 2026
Trial ID	jRCT2071260067

Scientific Title	ONO-3401-01: A Phase I, Placebo-controlled, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of ONO - 3401 in Japanese Healthy Adult Male Participants
Public Title	ONO-3401-01: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-3401 in Japanese Healthy Adult Male Participants

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	+81-120278120
	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	+81-120278120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 28, 2026
Target sample size		66
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	1) Japanese healthy adult male Participants 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 currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, or endocrine function. 2) The participant has a lifetime history of suicidal ideation or suicide attempt. 3) Presence or history of severe allergy to drugs or food 4) Presence or history of drug or alcohol dependence
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy Adult Male Participants
Intervention(s)		1) Single oral dose part ONO-3401 or placebo will be administered as a single oral dosing 2) Multiple oral dose part ONO-3401 or placebo will be administered as a multiple oral dosing
Primary Outcome(s)		Safety, Tolerability
Secondary Outcome(s)		Pharmacokinetics

Primary Sponsor	Ono Pharmaceutical Co.,LTD.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
E-Mail	miyako-koga@lta-med.com
Date of approval	Aug. 27, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 01, 2026	(this page)	Changes
1	July. 28, 2026	Detail

List of change history