Healthy Subjects
Conditions
Keywords
Peginterferon, Healthy subject, Pharmacokinetics, Pharmacodynamics, Safety
Brief 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.
Interventions
s,c, 45mcg of Ypeginterferon alfa-2a
s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
DRUGPeginterferon alfa-2a
s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Sponsors
Xiamen Amoytop Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring interferon levels in blood samples | from 0 to 408 hours following injection |
| Different blood interferon biomarkers (such as 2,5-OAS, neopterin) | from 0 to 408 hours following injection |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | up to 3 weeks following injection |
| Anti-interferon antibody | baseline and week 2 after injection |
Countries
China
Outcome results
None listed