Phase II/III of Recombinant Human Serum Albumin

Inclusion Criteria:

1. Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolledin the group, and signed the informed consent in person;
2. Age ≥18 years old and ≤70 years old, regardless of gender, on the date of signing theinformed consent; Body mass index (BMI) was in the range of 18.0 to 29.0 kg/m2 (including boundary values);
3. Patients clinically diagnosed with decompensated cirrhosis with ascites of grade 1 tograde 2 and serum albumin (ALB) <30 g/L were confirmed by abdominal ultrasoundexamination during the screening period.
4. Fertile men and women of childbearing age (women of childbearing age includepremenopausal women and women within 2 years after menopause) are willing to sign theinformed consent from the time after the last administration of the investigationaldrug 3 Take effective contraceptive measures (condom, contraceptive sponge,contraceptive gel, contraceptive film, intrauterine device, oral or injectablecontraceptive, subcutaneous implant, etc.) within a month; Pregnancy test results mustbe negative for women of childbearing age within 7 days or less before the initialtrial drug administration.

Exclusion Criteria:

1. People who have a known history of allergy/allergic reaction to yeast or yeast-derivedproducts, or to any component of the study preparation; Allergic constitution (multiple drug or food allergy), or have a history of biological product allergy,other causes Had a history of severe systemic anaphylaxis and was judged by theinvestigator to be unsuitable for treatment with the experimental drug;
2. At the time of screening, there were severe digestive diseases and complications thatwere deemed unsuitable for participation in this study by the investigators, includingbut not limited to malignant ascites and a diagnosis of Grade III or IV liveraccording to the West-Haven grading criteria Patients with encephalopathy, portal veincancer thrombus/thrombus, circulatory dysfunction after abdominal puncture,obstructive biliary tract disease identified by ultrasound or other imaging,gastrointestinal bleeding who stopped bleeding less than 10 days after treatment ordid not effectively stop bleeding after endoscopic ligation, or who were at greaterrisk of bleeding during the trial as assessed by the investigator (e.g., beforescreening) Gastroscopy within 3 months indicated severe esophageal and fundus variceswith positive red sign);
3. At the time of screening, there was a history of active cardiovascular disease orother conditions that the investigator judged unsuitable for human albumin therapy,including, but not limited to, hypertension (systolic blood pressure >140 mmHg ordiastolic blood pressure >90 mmHg, The investigators judged that patients were wellcontrolled and stable), severe anemia, acute heart disease, severe cardiopulmonary orstructural heart disease, severe arrhythmia, decompensated heart failure (normal orhigh blood volume), unstable angina, and nearly 6 Myocardial infarction, medicatedtachycardia/bradycardia, third-degree atrioventricular block occurred within a month;
4. Patients with active metabolic system diseases or medical history (except diabeticpatients with good blood glucose control) at the time of screening, or patients withcombined renal function injury who are not suitable for serum albumin treatmentaccording to the investigators;
5. If there are serious underlying diseases during screening, the researchers think it isnot suitable to participate in this study. These include, but are not limited to,active malignancies (including hepatocellular carcinoma [HCC]), pulmonary edema,bleeding prone or active bleeding diseases, uncontrolled infections (including activespontaneous bacterial peritonitis [SBP]), thyroid dysfunction (according to theNational Cancer Institute Standard for Common Terminology for Adverse Events [NCICTCAE] version 5.0 3 Grade and above), etc.;
6. The patient has the following abnormalities in laboratory examination:

(1). Liver function: alanine aminotransferase (ALT) > 5×ULN (upper limit of normal value);Aspartate aminotransferase (AST) >5×ULN; Serum bilirubin (TBIL) >4× the upper limit ofnormal (ULN) or was deemed unsuitable for trial participation by the investigator; (2)Renal function: serum creatinine >3× upper limit of normal (ULN), urine protein positiveand deemed unfit for study; (3) Bone marrow function: absolute value of neutrophil (ANC) <1.0×10^9/L; Platelet (PLT) <20×10^9/L; Hemoglobin (HGB) <70 g/L; (4) Coagulation function:prothrombin time (PT) extended >5s; 7. Persons who have been treated with human plasmapreparations (including human blood albumin preparations) within 7 days prior to theinitial administration of the experimental drug; People with a history of organtransplantation; Those who need or plan to undergo interventional invasive testing ortherapy during the study; 8. Those who have participated in or are participating inclinical trials of other new drugs or medical devices and have used investigationaldrugs/investigational treatments within 30 days prior to screening; 9. Those who testpositive for antibodies to the human immunodeficiency virus (HIV); 10. Pregnant orlactating women; 11. Other reasons why the researcher considered it inappropriate toparticipate in the study.