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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Treatments: Interferon-alpha; Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• Healthy subjects

• Age between 18 and 45, inclusive

• Body mass index(BMI)between 19 and 26, inclusive

• Sign informed consent

Exclusion Criteria:

• Women of pregnant or lactation

• Known hypersensitivity to interferon or any other components of the study drug

• History of mental disease or genetic disease

• History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant

• Significant disease in heart, liver, kidney, lung or any other major organs

• Alcoholic, smokers or drug abusers

• Blood donation, or massive blood loss due to injury or surgery within 3 months

• Other conditions which in the opinion of the investigator preclude enrollment into the study