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Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers

NCT01901198 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-11-17

No results posted yet for this study

Summary

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.

Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0

BIOLOGICAL

Peginterferon 180 mcg single dose S.C.

Pegasys 180 mcg S.C. single dose on Day 0

Sponsors & Collaborators

  • Beijing Bio-Fortune Ltd.

    lead INDUSTRY

Principal Investigators

  • Ning Li, MD · Beijing YouAn Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-09-30
Completion
2013-12-31

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 NCT01901198 on ClinicalTrials.gov