Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Type1 Diabetes Mellitus; Type2 Diabetes Mellitus

Treatments: Biological: HM12470

Study type: Interventional

Funder types: Industry

Identifiers

NCT03332849

HM-INS115-103

Details and patient eligibility

About

This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T1DM or T2DM
• Female subjects must be non-pregnant and non-lactating

Exclusion criteria

• Pregnant or lactating women
• Participation in an investigational study within 30 days prior to dosing

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Cohort 1

Experimental group

Description:

T1DM: Multiple dose subcutaneous administration

Treatment:

Biological: HM12470

Cohort 2

Experimental group

Description:

T1DM: Multiple dose subcutaneous administration

Treatment:

Biological: HM12470

Cohort 3

Experimental group

Description:

T2DM: Multiple dose subcutaneous administration

Treatment:

Biological: HM12470

Cohort 4

Experimental group

Description:

T2DM: Multiple dose subcutaneous administration

Treatment:

Biological: HM12470