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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01343186
First received: April 24, 2011
Last updated: January 30, 2012
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Peginterferon alfa
Drug: Peginterferon alfa 2a
Drug: Peginterferon alfa-2a
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Measuring interferon levels in blood samples [ Time Frame: from 0 to 408 hours following injection ] [ Designated as safety issue: No ]
  • Different blood interferon biomarkers (such as 2,5-OAS, neopterin) [ Time Frame: from 0 to 408 hours following injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: up to 3 weeks following injection ] [ Designated as safety issue: Yes ]
  • Anti-interferon antibody [ Time Frame: baseline and week 2 after injection ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Drug: Peginterferon alfa
s,c, 45mcg of Ypeginterferon alfa-2a
Arm 2 Drug: Peginterferon alfa 2a
s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Arm 3 Drug: Peginterferon alfa-2a
s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Arm 4 Drug: Peginterferon alfa-2a
s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343186

Locations
China
302 Military Hospital of China
Beijing, China, 100039
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Investigators
Principal Investigator: Wei Zhenman, Ph.D 302 Military Hospital of China
  More Information

No publications provided

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01343186     History of Changes
Other Study ID Numbers: TB1012IFN
Study First Received: April 24, 2011
Last Updated: January 30, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Peginterferon
Healthy subject
Pharmacokinetics
Pharmacodynamics
Safety

Additional relevant MeSH terms:
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014