drugset / Trial / NCT02356419
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
RandomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-01
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant erythropoietin stimulating protein | Protein / enzyme biologic | 0.5 ug/kg | Intravenous |
| Subject | Recombinant erythropoietin stimulating protein | Protein / enzyme biologic | 1 ug/kg | Intravenous |
| Subject | Recombinant erythropoietin stimulating protein | Protein / enzyme biologic | 2 ug/kg | Intravenous |
| Subject | Recombinant erythropoietin stimulating protein | Protein / enzyme biologic | 3 ug/kg | Intravenous |