NCT02781753

Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers

A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Tianjin SinoBiotech Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.

Detailed description

This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Human Serum Albumin/interferon alpha2b	Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0
BIOLOGICAL	Peginterferon 180 μg single dose S.C.	Pegasys 180 mcg S.C. single dose on Day 0

Timeline

• Start date: 2016-04-07
• Primary completion: 2016-08-02
• Completion: 2017-04-12
• First posted: 2016-05-24
• Last updated: 2017-05-08

Locations

1 site across 1 country: China