Status:
COMPLETED
Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Pharmacology
Eligibility:
All Genders
19-60 years
Phase:
PHASE1
Brief Summary
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
Eligibility Criteria
Inclusion
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
- Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit
Exclusion
- Subject with a history or presence of clinically significant active diseases.
- Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04076293
Start Date
October 8 2019
End Date
May 3 2021
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea, 05505