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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343186
• Other study ID #: TB1012IFN
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2011
• Last updated: January 30, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2010
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Peginterferon alfa
s,c, 45mcg of Ypeginterferon alfa-2a
• Peginterferon alfa 2a
s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
• Peginterferon alfa-2a
s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
• Peginterferon alfa-2a
s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Locations

Country	Name	City	State
China	302 Military Hospital of China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring interferon levels in blood samples		from 0 to 408 hours following injection	No
Primary	Different blood interferon biomarkers (such as 2,5-OAS, neopterin)		from 0 to 408 hours following injection	No
Secondary	Adverse events		up to 3 weeks following injection	Yes
Secondary	Anti-interferon antibody		baseline and week 2 after injection	Yes