Molar Potency Study of HM12470 in Healthy Subjects

Phase 1CompletedNCT03330327

Hanmi Pharmaceutical Company Limited56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

HM12470BIOLOGICAL

HM12470 is a long-acting insulin analogue

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hanmi Investigative Site

Chula Vista, California, United States

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

Cmax of HM12470

\- Maximum concentration of HM12470 over the entire dosing period

Time frame: 1 month

AUC of HM12470

\- Area Under the Curve of HM12470 over the entire dosing period

Time frame: 1 month

Data from ClinicalTrials.gov

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