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

January 30, 2012 updated by: Xiamen Amoytop Biotech Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100039
        • 302 Military Hospital of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Drug: Peginterferon alfa
s,c, 45mcg of Ypeginterferon alfa-2a
Other: Arm 2
Drug: Peginterferon alfa 2a
s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Other: Arm 4
Drug: Peginterferon alfa-2a
s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Drug: Peginterferon alfa-2a
s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Other: Arm 3
Drug: Peginterferon alfa-2a
s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Drug: Peginterferon alfa-2a
s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring interferon levels in blood samples
Time Frame: from 0 to 408 hours following injection
from 0 to 408 hours following injection
Different blood interferon biomarkers (such as 2,5-OAS, neopterin)
Time Frame: from 0 to 408 hours following injection
from 0 to 408 hours following injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: up to 3 weeks following injection
up to 3 weeks following injection
Anti-interferon antibody
Time Frame: baseline and week 2 after injection
baseline and week 2 after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Investigators

  • Principal Investigator: Wei Zhenman, Ph.D, Beijing 302 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

April 24, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (Estimate)

April 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB1012IFN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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