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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014