Shenzhen Projee Medical Technology Co., Ltd.

Phase II stage ? Main purpose: To evaluate the efficacy of recombinant human serum albumin in improving serum albumin levels in patients with cirrhosis and ascites, as well as the relationship between dose and efficacy. ? Secondary objectives: 1) To evaluate the safety of recombinant human serum albumin in subjects with cirrhosis and ascites; 2) To evaluate the pharmacodynamic (PD) characteristics of recombinant human serum albumin in subjects with cirrhosis and ascites; 3) To evaluate the immunogenicity of recombinant human serum albumin in subjects with cirrhosis and ascites. ? Exploratory purpose: To evaluate the effect of recombinant human serum albumin on glycated albumin in patients with cirrhosis and ascites. Phase III stage ? Main purpose: To evaluate the efficacy of recombinant human serum albumin in patients with cirrhosis and ascites, using the change in serum albumin concentration from baseline immediately after the last intravenous administration as an indicator. ? Secondary objectives: 1) To evaluate the efficacy of recombinant human serum albumin in patients with cirrhosis and ascites based on other efficacy evaluation indicators; 2) To evaluate the safety of recombinant human serum albumin in subjects with cirrhosis and ascites; 3) To evaluate the pharmacodynamic (PD) characteristics of recombinant human serum albumin in subjects with cirrhosis and ascites; 4) To evaluate the immunogenicity of recombinant human serum albumin in subjects with cirrhosis and ascites.

1. Evaluate the safety and tolerability of recombinant human serum albumin in subjects with cirrhosis and ascites, and determine the recommended dosage or range in later clinical studies. 2. Evaluate the immunogenicity, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics and preliminary effectiveness of recombinant human serum albumin in subjects with cirrhosis and ascites.

Primary objective To evaluate the safety of recombinant human serum albumin in healthy subjects. Secondary objectives To evaluate the pharmacokinetic (PK) characteristics of recombinant human serum albumin in healthy subjects; To evaluate the pharmacodynamic (PD) characteristics of recombinant human serum albumin in healthy subjects by the change of plasma colloidal osmotic pressure compared with the baseline; To evaluate the anti-drug antibody (ADA) response characteristics of recombinant human serum albumin in healthy subjects.