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Molar Potency Study of HM12470 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330327
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: HM12470 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects
Actual Study Start Date : March 30, 2015
Actual Primary Completion Date : August 17, 2017
Actual Study Completion Date : August 17, 2017

Arm Intervention/treatment
Experimental: Part 1
Intravenous (IV) infusion of HM12470
Biological: HM12470
HM12470 is a long-acting insulin analogue

Experimental: Part 2: Sequence 1
Intravenous (IV) infusion of HM12470
Biological: HM12470
HM12470 is a long-acting insulin analogue

Experimental: Part 2: Sequence 2
Intravenous (IV) infusion of HM12470
Biological: HM12470
HM12470 is a long-acting insulin analogue




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cmax of HM12470 [ Time Frame: 1 month ]
    - Maximum concentration of HM12470 over the entire dosing period

  2. AUC of HM12470 [ Time Frame: 1 month ]
    - Area Under the Curve of HM12470 over the entire dosing period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330327


Locations
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United States, California
Hanmi Investigative Site
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03330327    
Other Study ID Numbers: HM-INS-115-102
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No