NCT01343186

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

A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Peginterferon alfa	s,c, 45mcg of Ypeginterferon alfa-2a
DRUG	Peginterferon alfa 2a	s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
DRUG	Peginterferon alfa-2a	s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
DRUG	Peginterferon alfa-2a	s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-05-01
• Completion: 2011-11-01
• First posted: 2011-04-27
• Last updated: 2012-01-31

Locations

1 site across 1 country: China