drugset / Trial / NCT05249374

Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

NCT05249374

Phase 1 Completed 36 enrolled Protgen Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.

Timeline

Start
2021-10-14
Primary completion
2022-05-16
Completion
2022-05-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED Protein / enzyme biologic 10 g Intravenous
Comparator HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED Protein / enzyme biologic 20 g Intravenous
Comparator HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED Protein / enzyme biologic 30 g Intravenous
Subject Human serum albumin Protein / enzyme biologic 10 g Intravenous

Indications

No indication recorded.