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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Biological: HM12470; Biological: Active comparator

• Registration Number: NCT02302443
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Study Start: 2015-01
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 5	Active comparator	Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
Cohort 4	HM12470	High dose of HM12470 (single dose, subcutaneous injection)
Cohort 1	HM12470	Very low dose of HM12470 (single dose, subcutaneous injection)
Cohort 3	HM12470	Intermediate dose of HM12470 (single dose, subcutaneous injection)
Cohort 2	HM12470	Low dose of HM12470 (single dose, subcutaneous injection)
Cohort 6	Active comparator	Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
Cohort 5	HM12470	Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
Cohort 6	HM12470	Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent adverse events	1 month

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration(Cmax) of HM12470 following a single dose	1 month	Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
Area under the concentration-time curve (AUC) of HM12470 following a single dose	1 month	Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay

Trial Locations

Locations (1)

Hanmi Pharmaceutical Company; 🇰🇷 Seoul, Korea, Republic of