Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT01343186
- Lead Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Peginterferon alfa - Arm 2 Peginterferon alfa 2a - Arm 3 Peginterferon alfa-2a - Arm 4 Peginterferon alfa-2a -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse events up to 3 weeks following injection Anti-interferon antibody baseline and week 2 after injection
Trial Locations
- Locations (1)
302 Military Hospital of China
🇨🇳Beijing, China