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

NCT ID: NCT01343186

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Healthy Subjects

Keywords

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Peginterferon Healthy subject Pharmacokinetics Pharmacodynamics Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type OTHER

Peginterferon alfa

Intervention Type DRUG

s,c, 45mcg of Ypeginterferon alfa-2a

Arm 2

Group Type OTHER

Peginterferon alfa 2a

Intervention Type DRUG

s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Arm 3

Group Type OTHER

Peginterferon alfa-2a

Intervention Type DRUG

s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Arm 4

Group Type OTHER

Peginterferon alfa-2a

Intervention Type DRUG

s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Interventions

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Peginterferon alfa

s,c, 45mcg of Ypeginterferon alfa-2a

Intervention Type DRUG

Peginterferon alfa 2a

s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Intervention Type DRUG

Peginterferon alfa-2a

s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Intervention Type DRUG

Peginterferon alfa-2a

s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Zhenman, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

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302 Military Hospital of China

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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TB1012IFN

Identifier Type: -

Identifier Source: org_study_id