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

Xiamen Amoytop Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Peginterferon alfa-2a

Drug: Peginterferon alfa

Drug: Peginterferon alfa 2a

Study type

Interventional

Funder types

Industry

Identifiers

NCT01343186

TB1012IFN

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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