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

NCT01343186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-01-31

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Peginterferon alfa

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

DRUG

Peginterferon alfa 2a

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

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.

Sponsors & Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Zhenman, Ph.D · Beijing 302 Hospital

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-05-31
Completion
2011-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343186 on ClinicalTrials.gov