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ONO-1110-03 : A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-1110 in Healthy Japanese Adult Male Subjects

ONO-1110-03 : An Open-label Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-1110 after Single Oral Administration in Japanese Healthy Adult Male Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071240014
Enrollment
6
Registered
2024-05-21
Start date
2024-06-07
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

Interventions

Subjects receive a single oral dose of 180-mg ONO-1110.

Sponsors

Namba Yoshinobu
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese adult males 2) The subject is aged 18 to 45 years, inclusive, at the time of signing the informed consent form. 3) The subject has a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 (rounded down to 2 decimal places) at screening.

Exclusion criteria

Exclusion criteria: 1) An individual who is receiving treatment for or has a history of a respiratory, cardiovascular, psychiatric, neurological, gastrointestinal, immunological, hepatic, renal, hematopoietic, endocrine, or other disease 2) Subjects with current or perious history of severe allergy to drugs or food 3) The subject who is judged by the investigator or subinvestigator to be inappropriate as a subject of this study based on the results of screening tests

Design outcomes

Primary

MeasureTime frame
Plasma ONO-1110 concentrations and pharmacokinetic parameters

Secondary

MeasureTime frame
Adverse events that occurred after administration of investigational product until the end of final examination

Contacts

Public ContactCenter Medical

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-626-190

Outcome results

None listed

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