Molar Potency Study of HM12470 in Healthy Subjects

October 31, 2017 updated by: Hanmi Pharmaceutical Company Limited

An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects

This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Hanmi Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of HM12470
Time Frame: 1 month
- Maximum concentration of HM12470 over the entire dosing period
1 month
AUC of HM12470
Time Frame: 1 month
- Area Under the Curve of HM12470 over the entire dosing period
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2015

Primary Completion (Actual)

August 17, 2017

Study Completion (Actual)

August 17, 2017

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HM-INS-115-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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