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

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

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.

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