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Clinical Trial Summary

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.


Clinical Trial Description

This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03294798
Study type Interventional
Source Tianjin SinoBiotech Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 13, 2017
Completion date March 15, 2021

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