Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus
Phase 1
Terminated
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Biological: HM12460A
- Registration Number
- NCT03332836
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Type 2 diabetes mellitus
- Female subjects must be non-pregnant and non-lactating
Exclusion Criteria
- Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the Investigator
- 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 HM12460A Single dose subcutaneous administration (Dose A) Cohort 2 HM12460A Single dose subcutaneous administration (Dose B) Cohort 3 HM12460A Single dose subcutaneous administration (Dose C)
- 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 HM12460A 1 month - Maximum concentration of HM12460A over the entire dosing period
AUC of HM12460A 1 month - Area Under the Curve of HM12460A over the entire dosing period
Trial Locations
- Locations (1)
Hanmi Investigative Site
🇺🇸Chula Vista, California, United States