Phase 2 Study of F573 Injection Given by Intramuscular Injection for Treating Liver Injury and Liver Failure in Adults

What this Trial Is About

Researchers are evaluating the safety of F573 for injection in patients with various types of liver injury, including drug-induced liver injury DILI, chronic hepatitis B CHB, and intrahepatic cholestatic liver injury. This Phase II randomized, double-blind, placebo-controlled clinical trial aims to understand how F573 affects patients at risk of liver failure due to these injuries. The study is conducted in multiple stages. In the first stage, 25 patients receive different doses of F573 or a placebo via intramuscular injection once daily for 7 days. The second stage enrolls 24 patients treated with F573 or placebo at two dose levels once daily for 14 days. The third stage involves a 28-day treatment period with daily intramuscular injections of F573 or placebo, alongside acetylcysteine injection as basic treatment. Dosages are adjusted based on patient weight and earlier trial results. Participants undergo a screening period of 14 days before treatment and a follow-up period of 90 days after treatment completion. Throughout the study, patients receive various assessments including laboratory blood and urine tests, vital sign monitoring, physical exams, electrocardiograms, liver ultrasounds, and biomarker evaluations. Researchers monitor for adverse events, liver function scores, survival status, and medication use to evaluate safety and effects of the treatment.

F573 for Injection for the Treatment of Liver Injury/Failure