drugset / Trial / NCT02356419

rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics

NCT02356419 ↗

Phase 1 Unknown 40 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
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

EvaluationDrugModalityDoseRoute
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