Molar Potency Study of HM12470 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Subjects
- Registration Number
- NCT03330327
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Females must be non-pregnant and non-lactating
- Males must be surgically sterile or using an acceptable contraceptive method
Exclusion Criteria
- Participation in an investigational study within 30 days prior to dosing
- Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period 1 month - Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion
- Secondary Outcome Measures
Name Time Method Cmax of HM12470 1 month - Maximum concentration of HM12470 over the entire dosing period
AUC of HM12470 1 month - Area Under the Curve of HM12470 over the entire dosing period
Trial Locations
- Locations (1)
Hanmi Investigative Site
🇺🇸Chula Vista, California, United States
Hanmi Investigative Site🇺🇸Chula Vista, California, United States