Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05689645 | F573 for Injection for the Treatment of Liver Injury/Failure | PHASE2 | RECRUITING | 97 | — | — | Mar 24, 2023 | Sep 1, 2026 | Nov 19, 2025 | 10 | China |
to record Adverse events and serious adverse events in the trial
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
urine routine report contains the following values: GLU,PRO,RBC,WBC.
blood coagulation function report contains the following values: TT, APTT, PT, INR.
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
All-cause mortality within 28 days after completion of dosing.
| Arm | Type | Description |
|---|---|---|
| F573 for injection groups | EXPERIMENTAL | The first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit. The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit. The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest |
| Placebo Comparator | PLACEBO_COMPARATOR | 1. The first stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 7 days. Basic treatment: enteric-coated diammonium glycyrrhizinate capsules were administered at a dose of 150 mg 3 times a day. 2. The second stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 14 days. Basic treatment: Polyene phosphatidylcholines and glutathione drugs (no restricted dosage forms) are accepted as basic treatment. 3. The third stage: the Screen eligible subjects were treated with Sterilizing water for injection. The dose volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days. Basic treatment: receive acetylcysteine injection at a dose of 8 g / d once a day. |
| Name | Type | Description |
|---|---|---|
| F573 for injection | DRUG | The first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit. The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit. The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest . |
| Sterilizing water for injection | DRUG | The composition of this product is water for injection, and the dosage volume is 2mL for intramuscular injection. Medication course: The first stages were administered once a day for 7 days and second stages were administered once a day for 14 days. The third stage was administered once a day for 28 days. |
Inclusion Criteria: （1）The first stage: Participants who meet all of the following criteria will be enrolled in the study: 1. Age ≥18 and ≤60 years old, gender is not limited; 2. Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepa...