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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