Molar Potency Study of HM12470 in Healthy Subjects
Overview
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.
Full Title of Study: “An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 17, 2017
Interventions
- Biological: HM12470
- HM12470 is a long-acting insulin analogue
Arms, Groups and Cohorts
- Experimental: Part 1
- Intravenous (IV) infusion of HM12470
- Experimental: Part 2: Sequence 1
- Intravenous (IV) infusion of HM12470
- Experimental: Part 2: Sequence 2
- Intravenous (IV) infusion of HM12470
Clinical Trial Outcome Measures
Primary Measures
- Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period
- Time Frame: 1 month
- – Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion
Secondary Measures
- Cmax of HM12470
- Time Frame: 1 month
- – Maximum concentration of HM12470 over the entire dosing period
- AUC of HM12470
- Time Frame: 1 month
- – Area Under the Curve of HM12470 over the entire dosing period
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Provider of Information About this Clinical Study
- Sponsor
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