- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330314
Molar Potency Study of HM12460A in Healthy Subjects
August 11, 2020 updated by: Hanmi Pharmaceutical Company Limited
An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects
This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
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
-
-
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
Yes
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:
- 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 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
|
HM12460A is a long-acting insulin
|
Experimental: Part 2: Cohort A
Intravenous (IV) infusion (Dose A)
|
HM12460A is a long-acting insulin
|
Experimental: Part 2: Cohort B
Intravenous (IV) infusion (Dose B)
|
HM12460A is a long-acting insulin
|
Experimental: Part 2: Cohort C
Intravenous (IV) infusion (Dose C)
|
HM12460A is a long-acting insulin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period
Time Frame: 1 month
|
- Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of HM12460A
Time Frame: 1 month
|
- Maximum concentration of HM12460A over the entire dosing period
|
1 month
|
AUC of HM12460A
Time Frame: 1 month
|
- Area Under the Curve of HM12460A over the entire dosing period
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 24, 2017
Primary Completion (Actual)
February 8, 2018
Study Completion (Actual)
February 8, 2018
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)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- HM-INS-103
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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