Molar Potency Study of HM12470 in Healthy Subjects

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: HM12470

Study type: Interventional

Funder types: Industry

Identifiers

NCT03330327

HM-INS-115-102

Details and patient eligibility

About

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

Enrollment: 56 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

Part 1

Experimental group

Description:

Intravenous (IV) infusion of HM12470

Treatment:

Biological: HM12470

Part 2: Sequence 1

Experimental group

Description:

Intravenous (IV) infusion of HM12470

Treatment:

Biological: HM12470

Part 2: Sequence 2

Experimental group

Description:

Intravenous (IV) infusion of HM12470

Treatment:

Biological: HM12470