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The study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
The study is a single center and open test, and the dose of successive incremental method was taken. The study included 4 groups that is 0.5 ug/kg, 1.0ug/kg, 2.0ug/kg and 3.0ug/kg,the pharmacokinetic data (the screening period, before administration, after administration of 15, 30, 60 minutes, fourth, 8, 12, 24, 36, 48, 72 hours, seventh, 10, 14, 21, 28 days, 10 cases in each group) were collected. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental 0.5 ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
|
| experimental 1.0ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
|
| experimental 2.0ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
|
| experimental 3.0ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant erythropoietin stimulating protein | Drug | Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites |
| Measure | Description | Time Frame |
|---|---|---|
| Reticulocyte counts | observe the reticulocyte counts and judge whether rESP could improve anemia | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin counts | observe the hemoglobin counts and judge whether rESP could improve anemia | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Limei Zhao, doctor | Contact | 8624-96615 | zhaolm@sj-hospital.org | |
| feng qiu, doctor | Contact | 8624-96615 | zhaolm@sj-hospital.org |
| Name | Affiliation | Role |
|---|---|---|
| Limei Zhao, doctor | Shengjing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital affiliated to China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
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|
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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