Phase II/III of Recombinant Human Serum Albumin

Inclusion Criteria:

1. Agreed to follow the experimental treatment plan and visit plan, voluntarilyenrolled in 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 signingthe informed 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 1to grade 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 signthe informed consent from the time after the last administration of theinvestigational drug 3 Take effective contraceptive measures (condom, contraceptivesponge, contraceptive gel, contraceptive film, intrauterine device, oral orinjectable contraceptive, subcutaneous implant, etc.) within a month; Pregnancy testresults must be negative for women of childbearing age within 7 days or less beforethe initial trial drug administration.

Exclusion Criteria:

1. People who have a known history of allergy/allergic reaction to yeast oryeast-derived products, or to any component of the study preparation; Allergicconstitution (multiple drug or food allergy), or have a history of biologicalproduct allergy, other causes Had a history of severe systemic anaphylaxis and wasjudged by the investigator to be unsuitable for treatment with the experimentaldrug;

2. At the time of screening, there were severe digestive diseases and complicationsthat were deemed unsuitable for participation in this study by the investigators,including but not limited to malignant ascites and a diagnosis of Grade III or IVliver according to the West-Haven grading criteria Patients with encephalopathy,portal vein cancer thrombus/thrombus, circulatory dysfunction after abdominalpuncture, obstructive biliary tract disease identified by ultrasound or otherimaging, gastrointestinal bleeding who stopped bleeding less than 10 days aftertreatment or did not effectively stop bleeding after endoscopic ligation, or whowere at greater risk of bleeding during the trial as assessed by the investigator (e.g., before screening) Gastroscopy within 3 months indicated severe esophageal andfundus varices with 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 cardiopulmonaryor structural heart disease, severe arrhythmia, decompensated heart failure (normalor high blood volume), unstable angina, and nearly 6 Myocardial infarction,medicated tachycardia/bradycardia, third-degree atrioventricular block occurredwithin 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 itis not 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 (includingactive spontaneous bacterial peritonitis [SBP]), thyroid dysfunction (according tothe National Cancer Institute Standard for Common Terminology for Adverse Events [NCI CTCAE] 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 of normal (ULN) or was deemed unsuitable for trial participation by the investigator; (2) Renal function: serum creatinine >3× upper limit of normal (ULN), urine protein positive and 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 plasma preparations (including human blood albumin preparations) within 7 days prior to the initial administration of the experimental drug; People with a history of organ transplantation; Those who need or plan to undergo interventional invasive testing or therapy during the study; 8. Those who have participated in or are participating in clinical trials of other new drugs or medical devices and have used investigational drugs/investigational treatments within 30 days prior to screening; 9. Those who test positive for antibodies to the human immunodeficiency virus (HIV); 10. Pregnant or lactating women; 11. Other reasons why the researcher considered it inappropriate to participate in the study.