Molar Potency Study of HM12460A in Healthy Subjects

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: HM12460A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03330314

HM-INS-103

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 4 patient groups

Part 1

Experimental group

Description:

Intravenous (IV) infusion

Treatment:

Biological: HM12460A

Part 2: Cohort A

Experimental group

Description:

Intravenous (IV) infusion (Dose A)

Treatment:

Biological: HM12460A

Part 2: Cohort B

Experimental group

Description:

Intravenous (IV) infusion (Dose B)

Treatment:

Biological: HM12460A

Part 2: Cohort C

Experimental group

Description:

Intravenous (IV) infusion (Dose C)

Treatment:

Biological: HM12460A