drugset
drugset / Trial / NCT01800305

PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual

NCT01800305 ↗

Phase 1 Completed 150 enrolled Xiamen Amoytop Biotech Co., Ltd.
RandomizedParallel-groupOpen-label

Summary

The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.

Timeline

Start
2012-09
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegylated rhEPO Unknown 0.5 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 1 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 1.6 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 2.4 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 3.2 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 4.2 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 5.5 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 7.2 ug/kg Subcutaneous
Subject Pegylated rhEPO Unknown 9.3 ug/kg Subcutaneous
Comparator epoetin alfa Protein / enzyme biologic 50 iu/kg Subcutaneous
Comparator epoetin alfa Protein / enzyme biologic 150 iu/kg Subcutaneous

Indications

No indication recorded.