ONO-2416-01: A phase I study to evaluate the safety, tolerability, and pharmacokinetics of ONO-2416 in Japanese healthy adult male subjects

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250147

Enrollment

Registered

2026-03-24

Start date

2026-04-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers(The planned indication has not been determined.)

Interventions

- 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

Eligibility

Sex/Gender

Male

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
Mass balance (Part C only), Electroencephalogram (Part D only)	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD.

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026