Molar Potency Study of HM12470 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330327
• Other study ID #: HM-INS-115-102
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2017
• Last updated: October 31, 2017
• Start date: March 30, 2015
• Est. completion date: August 17, 2017

Study information

• Verified date: October 2017
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• 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:

• 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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• HM12470
HM12470 is a long-acting insulin analogue

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 HM12470 and regular human insulin (RHI) over the entire dosing period	- Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion	1 month
Secondary	Cmax of HM12470	- Maximum concentration of HM12470 over the entire dosing period	1 month
Secondary	AUC of HM12470	- Area Under the Curve of HM12470 over the entire dosing period	1 month