Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
- Registration Number
- NCT04076293
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HM15912 HM15912 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events of HM15912 after single subcutaneous (SC) doses for 44 days Number of participants with any treatment-emergent adverse events related to study medication.
Number of Participants With Significant Findings Observed for Hematology after single subcutaneous (SC) doses for 44 days
- Secondary Outcome Measures
Name Time Method Concentration Max Profile of HM15912 after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30 To assess the Concentration Max profile of HM15912 after single SC doses.
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of