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This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Intravenous (IV) infusion |
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| Part 2: Cohort A | Experimental | Intravenous (IV) infusion (Dose A) |
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| Part 2: Cohort B | Experimental | Intravenous (IV) infusion (Dose B) |
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| Part 2: Cohort C | Experimental | Intravenous (IV) infusion (Dose C) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM12460A | Biological | HM12460A is a long-acting insulin |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period | - Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of HM12460A | - Maximum concentration of HM12460A over the entire dosing period | 1 month |
| AUC of HM12460A | - Area Under the Curve of HM12460A over the entire dosing period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Investigative Site | Chula Vista | California | 91911 | United States |
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| 1 month |