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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Peginterferon 180 μg single dose S.C.; Biological: Human Serum Albumin/interferon alpha2b

• Registration Number: NCT02781753
• Lead Sponsor: Tianjin SinoBiotech Ltd.

Brief 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.

Study Timeline

• Study Start: 2016-04-07
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-24
• Primary Completion: 2016-08-02
• Status Verified: 2017-04
• Study Completion: 2017-04-12
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegasys	Peginterferon 180 μg single dose S.C.	Peginterferon 180 μg single dose S.C.
Human Serum Albumin/interferon alpha2b	Human Serum Albumin/interferon alpha2b	Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events after single dose	4 weeks	Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of Neopterin after single dose	4 weeks	Plasma concentration of Neopterin after single dose
Pharmacokinetics of interferon after single dose	4 weeks	Half-life period(T1/2)

Trial Locations

Locations (1)

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