Shenzhen Projee Medical Technology Co., Ltd.

Phase III stage Main purpose: Using the change of serum albumin concentration from baseline immediately after the last intravenous administration as an indicator, evaluate the efficacy of recombinant human serum albumin in patients with cirrhosis and ascites. Secondary objectives: 1) Evaluate the efficacy of recombinant human serum albumin in patients with cirrhosis and ascites based on other efficacy evaluation indicators; 2) Evaluate the safety of recombinant human serum albumin in subjects with cirrhosis and ascites; 3) Evaluate the pharmacodynamic (PD) characteristics of recombinant human serum albumin in subjects with cirrhosis and ascites; 4) 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 and glycated hemoglobin in patients with cirrhosis and ascites.

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.