drugset / Trial / NCT01343186

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects

NCT01343186

Phase 1 Completed 39 enrolled Xiamen Amoytop Biotech Co., Ltd.
RandomizedParallel-groupTriple-blind

Summary

This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.

Timeline

Start
2011-01
Primary completion
2011-05
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Subject Ypeginterferon alfa-2a Unknown 45 ug Subcutaneous
Subject Ypeginterferon alfa-2a Unknown 90 ug Subcutaneous
Subject Ypeginterferon alfa-2a Unknown 180 ug Subcutaneous
Subject Ypeginterferon alfa-2a Unknown 270 ug Subcutaneous

Indications

No indication recorded.