drugset / Trial / NCT03657238

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RD01 (Pegerythropoietin) in Healthy Chinese Volunteers

NCT03657238

Phase 1 Completed 84 enrolled Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A first-time in human study to investigate the safety, tolerability and pharmacokinetics of RD01 in healthy Chinese subjects

Timeline

Start
2018-04-08
Primary completion
2019-08-02
Completion
2019-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject RD01 Protein / enzyme biologic 0.2 ug/kg Subcutaneous
Subject RD01 Protein / enzyme biologic 0.4 ug/kg Subcutaneous
Subject RD01 Protein / enzyme biologic 0.8 ug/kg Subcutaneous
Subject RD01 Protein / enzyme biologic 1.6 ug/kg Subcutaneous
Subject RD01 Protein / enzyme biologic 2.4 ug/kg Subcutaneous
Subject RD01 Protein / enzyme biologic 3.6 ug/kg Subcutaneous
Subject RD01 Protein / enzyme biologic 4.8 ug/kg Subcutaneous

Indications

No indication recorded.