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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Very low dose of HM12470 (single dose, subcutaneous injection) |
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| Cohort 2 | Experimental | Low dose of HM12470 (single dose, subcutaneous injection) |
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| Cohort 3 | Experimental | Intermediate dose of HM12470 (single dose, subcutaneous injection) |
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| Cohort 4 | Experimental | High dose of HM12470 (single dose, subcutaneous injection) |
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| Cohort 5 | Experimental | Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection) |
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| Cohort 6 | Experimental | Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM12470 | Biological | Single dose subcutaneous administration ranging from a very low dose to high dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Area under the concentration-time curve (AUC) of HM12470 following a single dose |
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Inclusion Criteria for T1DM:
Inclusion Criteria for T2DM:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hanmi Pharmaceuticals Hanmi Pharmaceuticals | Hanmi Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Pharmaceutical Company | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Active comparator | Biological | Single dose subcutaneous administration of active comparator |
|
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay |
| 1 month |