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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.; Biological: Peginterferon 180 mcg single dose S.C.

• Registration Number: NCT01901198
• Lead Sponsor: Beijing Bio-Fortune Ltd.

Brief 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.

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 alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-17
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Must be healthy males or females between 18 to 45 years old, inclusive
• Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg

Exclusion Criteria

• History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
• Female subjects who are pregnant or breastfeeding
• Any previous treatment with Human Albumin Interferon fusion protein

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Serum Albumin/interferon alpha2a	Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.	Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.
Pegasys	Peginterferon 180 mcg single dose S.C.	Peginterferon 180 mcg single dose S.C.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events after single dose	4 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of interferon after single dose	4 weeks
Plasma concentration of Neopterin after single dose	4 weks

Trial Locations

Locations (1)

Beijing YouAn Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China