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

Tianjin SinoBiotech

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Peginterferon 180 μg single dose S.C.

Biological: Human Serum Albumin/interferon alpha2b

Study type

Interventional

Funder types

Industry

Identifiers

NCT02781753

921601

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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