NCT02302443

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

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Administration of HM12470 in Subjects With Type 1 (T1DM) and Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	HM12470	Single dose subcutaneous administration ranging from a very low dose to high dose
BIOLOGICAL	Active comparator	Single dose subcutaneous administration of active comparator

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-11-27
• Last updated: 2017-11-08

Locations

1 site across 1 country: South Korea