ONO-4915-01:ONO-4915 Phase I study A study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ONO-4915 in Japanese healthy adult males

ONO-4915-01:ONO-4915 Phase I study A Phase I randomized, single-blind, parallel-group study in Japanese healthy adult males to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ONO-4915 given as a single continuous intravenous dose, a single subcutaneous dose, and repeated subcutaneous doses

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240056

Enrollment

128

Registered

2024-09-11

Start date

2024-11-01

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

Auto immune disease

Interventions

1) Single intravenous infusion part ONO-4915 or placebo will be administered as a single intravenous infusion. 2) Single subcutaneous injection part ONO-4915 or placebo will be administered as a sing

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, Pharmacokinetics	—

Secondary

Measure	Time frame
Pharmacodynamics,Immunogenicity	—

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