Tianjin PuYing Biotechnology Co., Ltd.

To evaluate the efficacy and safety of recombinant human serum albumin/granulocyte stimulating factor fusion protein for injection in preventing chemotherapy-induced neutropenia and to provide a basis for safe and effective dosing regimens in phase III clinical trials.

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.

The research plan of this Phase I clinical trial aims to obtain data on the drug's safety, tolerability, initial effective dose and pharmacokinetics, and provide a scientific basis for the conduct of Phase II clinical research.