A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)
Phase 1
Completed
- Conditions
- Obesity
- Interventions
- Biological: HM15211 or Placebo
- Registration Number
- NCT03374241
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
Single ascending dose of HM15211 in healthy obese subjects.
- Detailed Description
A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
- Female subjects must be non-pregnant and non-lactating
Exclusion Criteria
- Participation in an investigational study within 30 days prior to dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 2 HM15211 or Placebo HM15211 or Placebo (single dose, subcutaneous injection) Cohort 1 HM15211 or Placebo HM15211 or Placebo (single dose, subcutaneous injection) Cohort 4 HM15211 or Placebo HM15211 or Placebo (single dose, subcutaneous injection) Cohort 5 HM15211 or Placebo HM15211 or Placebo (single dose, subcutaneous injection) Cohort 3 HM15211 or Placebo HM15211 or Placebo (single dose, subcutaneous injection)
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 1 month An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hanmi Investigative Site
🇺🇸Chula Vista, California, United States