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

Phase 1

• Conditions: Type1 Diabetes Mellitus; Type2 Diabetes Mellitus
• Interventions: Biological: HM12470

• Registration Number: NCT03332849
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-28
• Study First Submitted: 2017-10-26
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-01
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	HM12470	T1DM: Multiple dose subcutaneous administration
Cohort 3	HM12470	T2DM: Multiple dose subcutaneous administration
Cohort 4	HM12470	T2DM: Multiple dose subcutaneous administration
Cohort 2	HM12470	T1DM: Multiple dose subcutaneous administration

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	1 month	An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products.

Secondary Outcome Measures

Name	Time	Method
Cmax of HM12470	1 month	- Maximum concentration of HM12470 over the entire dosing period
AUC of HM12470	1 month	- Area Under the Curve of HM12470 over the entire dosing period

Trial Locations

Locations (1)

Hanmi Investigative Site; 🇺🇸 Chula Vista, California, United States