A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Biological: HM12470; Biological: Active comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02302443

HM-INS115-101

Details and patient eligibility

About

The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.

Full description

This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for T1DM:

• T2DM more than 12 monthM
• Age ≥18 and ≤70 years
• Body mass index between 18.0 and 35.0 kg/m2 inclusive.
• Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
• Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Inclusion Criteria for T2DM:

• T1DM more than 12 monthM
• Age ≥18 and ≤70 years
• Body mass index between 18.0 and 30.0 kg/m2 inclusive.
• Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
• Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Exclusion Criteria

• A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
• Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
• pregnant or lactating women
• participation in an investigational study within 30 days prior to dosing
• Clinically significant abnormal ECG at screening, as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Very low dose of HM12470 (single dose, subcutaneous injection)

Treatment:

Biological: HM12470

Cohort 2

Experimental group

Description:

Low dose of HM12470 (single dose, subcutaneous injection)

Treatment:

Biological: HM12470

Cohort 3

Experimental group

Description:

Intermediate dose of HM12470 (single dose, subcutaneous injection)

Treatment:

Biological: HM12470

Cohort 4

Experimental group

Description:

High dose of HM12470 (single dose, subcutaneous injection)

Treatment:

Biological: HM12470

Cohort 5

Experimental group

Description:

Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Treatment:

Biological: Active comparator

Biological: HM12470

Cohort 6

Experimental group

Description:

Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Treatment:

Biological: Active comparator

Biological: HM12470