Recombinant human serum albuminfrom OsrHSA (Wuhan Healthgen)

主要目的： 评价植物源重组人血清白蛋白注射液对肝硬化低白蛋白血症患者升高血清白蛋白浓度的有效性。 次要目的： 评价植物源重组人血清白蛋白注射液在肝硬化低白蛋白血症患者中的安全性； 评价植物源重组人血清白蛋白注射液在肝硬化低白蛋白血症患者中的免疫原性。

The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.