In a randomized, double-blind, placebo-controlled design, the study was divided into two phases according to the subjects' risk of liver failure due to liver injury.~The first stage: The 36 patients with 1/2 grade DILI and 12 patients with CHB were enrolled,Firstly, DILI patients were treated with trial drug 0.5, 1.0, 2.0 mg/kg or placebo in a 1:1:1:1 ratio,CHB patients received the trial drug or placebo in a 3:1 ratio, and the dose was determined based on the efficacy and safety results of the DILI patients.~The second stage:The 2/3 grade DILI patients and CHB patients were enrolled, 12 cases in each group, and they were assigned to the experimental group and the control group in a ratio of 3:1.the drug dose given was determined by the combination of efficacy and safety results in the first stage.~The study was divided into screening period (14 days), treatment period (14 days) and follow-up period (28 days).~Screening eligible subjects received the trial drug or placebo in a 3:1 ratio once daily for 14 consecutive days.~DILI subjects and CHB subjects should also use Diammonium glycyrrhizate enteric-coated capsules for basic treatment.After withdrawal, the subjects were followed up for 28 days for safety.~After obtaining subject consent, pharmacokinetic blood samples will be collected for CHB patients in stages 1 and 2 in this trial.~The Third stage:~This study used a randomized, double-blind, placebo-controlled design. The study was divided into screening period (14 days), treatment period (28 days) and follow-up period (90 days).~48 screen eligible subjects received trial drug or placebo in a ratio of 3:1, once a day for 28 days. The dose was determined according to the results of the efficacy and safety of the first and second stages. Subjects should also receive concurrent drug acetylcysteine injection (NAC). After withdrawal, the subjects were followed up for 90 days for safety.
This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .~The main objective of this study was to confirm the efficacy and safety of F573 for injection in the treatment of liver injury/failure.