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This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | T1DM: Multiple dose subcutaneous administration |
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| Cohort 2 | Experimental | T1DM: Multiple dose subcutaneous administration |
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| Cohort 3 | Experimental | T2DM: Multiple dose subcutaneous administration |
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| Cohort 4 | Experimental | T2DM: Multiple dose subcutaneous administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM12470 | Biological | HM12470 is a long-acting insulin analogue |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of HM12470 | - Maximum concentration of HM12470 over the entire dosing period | 1 month |
| AUC of HM12470 | - Area Under the Curve of HM12470 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 |