ONO-4685-04: ONO-4685 Phase 1 study

JRCT ID: jRCT2071220081

Registered date:23/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Auto immune disease
• Date of first enrollment: 17/01/2023
• Target sample size: 72
• Study type: Interventional
• Intervention(s): ONO-4685:Single-dose intravenous continuous infusion and subcutaneous administration

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: Namba Yoshinobu