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NCT03330314 Clinical Trial

Molar Potency Study of HM12460A in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:
An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03330314
Other study ID # HM-INS-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 24, 2017
Est. completion date February 8, 2018

Study information
Verified date August 2020
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date February 8, 2018
Est. primary completion date February 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• HM12460A
HM12460A is a long-acting insulin

Locations
Country Name City State
United States Hanmi Investigative Site Chula Vista California

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period - Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion 1 month
Secondary Cmax of HM12460A - Maximum concentration of HM12460A over the entire dosing period 1 month
Secondary AUC of HM12460A - Area Under the Curve of HM12460A over the entire dosing period 1 month
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