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The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated rhEPO | Experimental | Subcutaneous single-dose administration of 0.5mcg/kg, 1.0mcg/kg, 1.6 mcg/kg, 2.4 mcg/kg, 3.2 mcg/kg,3.2mcg/kg, 4.2mcg/kg, 5.5 mcg/kg, 7.2 mcg/kg, 9.3 mcg/kg (in dose-escalation, if the previous dose is confirmed to be safe.started with the second 3.2mcg/kg dose,Every subject takes Niferex 150mg every day, from day 1 to day 20. ) of the test drug (Pegylated rhEPO) |
|
| EPIAO® | Active Comparator | Subcutaneous six-dose administration of 50IU/kg or 150IU/kg, as randomization, of the comparator drug(EPIAO®) at day 1, 3, 5, 8, 10, 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated rhEPO | Drug |
| ||
| EPIAO® |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of rhEPO |
| 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration |
| Plasma reticulocyte count | For comparator drug, blood collection of 48, 96, 168, 216, and 264 hour should before drug administration | 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration. |
| Plasma hemoglobin concentration | For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration | 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration. |
| Plasma hematocrit | For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration | 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhenman, Ph.D | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Military Hospital of China | Beijing | China |
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