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The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JT1801 | Experimental |
| |
| NESP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JT1801 60ug | Drug | JT1801, 60ug, IV injection |
| |
| NESP 60ug |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-t | Pre-dose and after dose 20 days |
| AUC0-∞ | PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-∞ | Pre-dose and after dose 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| TEmax | PD parameters comparison between JT1801 and darbepoetin alfa: TEmax of reticulocyte count, hematocrit, hemoglobin concentration, RBC | Pre-dose and after dose 15 days |
| Emax | PD parameters comparison between JT1801 and darbepoetin alfa: Emax of reticulocyte count, hematocrit, hemoglobin concentration, RBC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 101149 | China |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Drug |
NESP, 60ug, IV injection |
|
| Pre-dose and after dose 15 days |
| AUEC0-t | PD parameters comparison between JT1801 and darbepoetin alfa: AUEC0-t of reticulocyte count, hematocrit, hemoglobin concentration, RBC | Pre-dose and after dose 15 days |
| ΔAUEC0-t | PD parameters comparison between JT1801 and darbepoetin alfa: ΔAUEC0-t of reticulocyte count, hematocrit, hemoglobin concentration, RBC | Pre-dose and after dose 15 days |
| ΔEmax | PD parameters comparison between JT1801 and darbepoetin alfa: ΔEmax of reticulocyte count, hematocrit, hemoglobin concentration, RBC | Pre-dose and after dose 15 days |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |