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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Single dose subcutaneous administration ranging from a very low dose to high dose
Single dose subcutaneous administration of active comparator
Hanmi Pharmaceutical Company
Seoul, South Korea
Incidence and severity of treatment emergent adverse events
Time frame: 1 month
Peak Plasma Concentration(Cmax) of HM12470 following a single dose
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
Time frame: 1 month
Area under the concentration-time curve (AUC) of HM12470 following a single dose
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
Time frame: 1 month
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