Status:
COMPLETED
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intra...
Detailed Description
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian health...
Eligibility Criteria
Inclusion
- Japanese healthy adult male subjects (PartA, B, and C)
- Caucasian healthy adult male subjects (Part D)
- Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas
- Body weight (at the time of screening test): ≥50 kg
Exclusion
- 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.
- Subjects with current or with a history of severe allergy to drugs or foods
- Subjects with current or with a history of drug or alcohol abuse
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04079062
Start Date
September 12 2019
End Date
May 25 2021
Last Update
May 3 2024
Active Locations (1)
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1
Fukuoka Clinical Site
Hakata, Fukuoka, Japan