Status:
COMPLETED
Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Fibrodysplasia Ossificans Progressiva
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
Eligibility Criteria
Inclusion
- Japanese healthy male subjects.
- Age ≥20 and ≤45 years upon providing informed consent.
- Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening.
Exclusion
- Have a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
- Have alcohol or drug dependence, etc.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04818398
Start Date
April 1 2021
End Date
July 26 2022
Last Update
August 3 2022
Active Locations (1)
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1
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan, 532-0003