Molar Potency Study of HM12460A in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Biological: HM12460A
- Registration Number
- NCT03330314
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- Females must be non-pregnant and non-lactating
- Males must be surgically sterile or using an acceptable contraceptive method
Exclusion Criteria
- History of any major surgery within 6 months prior to screening
- Use of any new prescription or non-prescription drug in the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Cohort A HM12460A Intravenous (IV) infusion (Dose A) Part 2: Cohort B HM12460A Intravenous (IV) infusion (Dose B) Part 2: Cohort C HM12460A Intravenous (IV) infusion (Dose C) Part 1 HM12460A Intravenous (IV) infusion
- Primary Outcome Measures
Name Time Method Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period 1 month - Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion
- Secondary Outcome Measures
Name Time Method Cmax of HM12460A 1 month - Maximum concentration of HM12460A over the entire dosing period
AUC of HM12460A 1 month - Area Under the Curve of HM12460A over the entire dosing period
Trial Locations
- Locations (1)
Hanmi Investigative Site
🇺🇸Chula Vista, California, United States