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Study design:
Primary Objective:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | The lowest dose level of HM10760A |
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| Cohort 2 | Experimental | Second dose level of HM10760A |
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| Cohort 3 | Experimental | Third dose level of HM10760A |
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| Cohort 4 | Experimental | Fourth dose level of HM10760A |
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| Cohort 5 | Experimental | The highest dose level of HM10760A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM10760A or placebo | Drug | Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level. | 84 days after the investigational drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Clinical | US | California | United States |
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