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

JRCT ID: jRCT2071240056

Registered date:11/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Auto immune disease
• Date of first enrollment: 01/11/2024
• Target sample size: 160
• Study type: Interventional

Intervention(s)

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 single subcutaneous injection.
3) Repeated subcutaneous injection part ONO-4915 or placebo will be repeatedly administered as subcutaneous injections.

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics
• Secondary Outcome: Pharmacodynamics,Immunogenicity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Terasawa Tetsuji