ONO-1110-01:Phase 1 study of the safety, tolerability, pharmacokinetics of ONO-1110 in healthy Japanese adult male subjects

ONO-1110-01:Single and multiple oral dose, placebo-controlled, double-blind, randomized, parallel-group, Phase 1 study of the safety, Tolerability, Pharmacokinetics of ONO-1110 in healthy Japanese adult male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220100

Enrollment

100

Registered

2023-01-31

Start date

2023-02-17

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

1) Part A:Single dose Part Subjects receive single oral dose of ONO-1110 or placebo. 2) Part B:Multiple dose Part Subjects receive multiple oral doses of ONO-1110 or placebo. 3) Part C:Cerebrospinal F

Eligibility

Sex/Gender

Male

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Safety (All Part), Pharmacokinetic (All Part), Compound concentration in cerebrospinal fluid (Part C only)	—

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