Tianjin Linda Biotechnology Co Ltd

To investigate the safety and tolerability of single and multiple doses of this product as well as its pharmacokinetic and pharmacodynamic indicators in patients with chronic hepatitis B, and to explore its preliminary clinical efficacy in the treatment of chronic hepatitis B.

To investigate the safety, tolerability, pharmacokinetic and pharmacodynamic indicators of this product in healthy subjects

Using standard dose of Pegasys (180μg/week) as positive control, chronic hepatitis B patients were selected as subjects to explore and evaluate the tolerance and safety of multiple subcutaneous injections of recombinant human serum albumin/interferon α2a fusion protein injection. At the same time, the pharmacokinetics and preliminary efficacy of the drug after single and multiple administrations in patients with chronic hepatitis B were studied, and the effective dose was explored to provide a basis for the formulation of safe and effective dosing regimens for Phase II and III clinical trials.