F573 for Injection for the Treatment of Liver Injury/Failure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial

KDN-F573-202202

This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial . The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), etc.).

2023-03-24

2025-09-25

2026-03-31

Recruiting

Early phase I

97

Inclusion Criteria:The first stage: Subjects who meet all of the following criteria will be enrolled in the study: 1. Age is 18 and 60 years old, gender is unlimited; 2. Patients with clinical diagnosis of hepatocyte injury or combination of liver injury or CHB who have been infected with hepatitis B virus for more than 6 months (refer to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)"), CHB patients may be screened for etiology (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results).Indicates that hepatitis B virus infection has been more than 6 months); 3. Serum ALT: 2\~ 10×ULN, TBil:\< 5 x ULN; 4. DILI patients: the abnormal duration of liver biochemical indexes \[ALT, AST, ALP, γ -glutamyl-transpeptidase (GGT), TBil, albumin, and prothrombin time\] is not more than 90 days; 5. Subjects (including their partners) are willing to voluntarily take effective contraception within 6 months from the screening period until the last trial drug was given; 6. Subjects can sign the informed consent and comply with the requirements of the protocol; If the subject cannot sign the informed consent, it shall be signed by the legal guardian or witness who required by regulations. (2)The second stage: Subjects who meet all of the following criteria will be enrolled in the study: 1. Age is 18 and 60 years old, and gender is unlimited; 2. Patients with clinical diagnosis of hepatocyte injury or combination of liver injury or CHB who have been infected with hepatitis B virus for more than 6 months (refer to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)"), CHB patients may be screened for etiology (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results).Indicates that hepatitis B virus infection has been more than 6 months); 3. Subject serum ALT: 5\~20 × upper limit of normal value (ULN), TBil: \<10 × ULN; 4. DILI patients: the abnormal duration of liver biochemical indexes \[ALT, AST, ALP, γ -glutamyl-transpeptidase (GGT), TBil, albumin, and prothrombin time\] is not more than 90 days; 5. Subjects (including their partners) are willing to voluntarily take effective contraception within 6 months from the screening period until the last trial drug was given; 6. Subjects can sign the informed consent and comply with the requirements of the protocol; If the subject cannot sign the informed consent, it shall be signed by the legal guardian or witness who required by regulations. The third stage: 1. Age is 18 and 70 years old, gender is unlimited; 2. Referring to the "Guidelines for the Diagnosis and Treatment of Liver Failure (2018 edition)" for patients diagnosed with Acute on chronic Liver Failure , TBil ≥5×ULN, 4 weeks with hepatic encephalopathy (grade 1-2) or ascites (grade 1-2) before screening period, and 5≤ AARC score≤10 (AARC rating of grade I-II); 3. Subjects (including their partners) were willing to voluntarily take effective contraception within 6 months from the screening period until the last trial drug was given. 4. Subjects can sign the informed consent and comply with the requirements of the protocol; If the subject cannot sign the informed consent, it shall be signed by the legal guardian or witness who required by regulations. - Exclusion Criteria: The first stage: Subjects meeting one of the following conditions will not be included in the trial: 1. According to the researchers, the subjects were patients with cholestatic liver injury. 2. Previous diagnosis of cirrhosis or the liver hardness determination in the screening time (LSM)≥12.4kPa; 3. Severe severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, patients with malignant tumors; 4. The following laboratory inspection values or inspection values are abnormal: 1. Blood routine: Platelet (PLT) \< 75×109/L , Hemoglobin (HGB) \< 90 g / L; 2. Prothrombin activity was \< 40%, and prothrombin time (PT) was prolonged for \> 5s; 3. Left ventricular ejection fraction (LVEF) was \<50%; 5. Allergic or intolerant to trial drugs, or allergic constitution; 6. Subjects were unable to express their own complaints, such as psychosis and severe neurosis; 7. Poor compliance and they cannot collaborate; 8. Pregnant women, lactating women, or women of childbearing age preparing to conceive; 9. Participating in other clinical trials within 3 months; 10. Patients who have used ursodeoxycholic acid other than adenosine methionine within 3 days before randomization; 11. The investigator considered any circumstances unsuitable for inclusion. The second stage: Subjects meeting one of the following conditions will not be included in the trial: 1. According to the researchers, the subjects were patients with cholestatic liver injury. 2. Previous diagnosis of cirrhosis or the liver hardness determination in the screening time (LSM)≥9.0 kPa;(LSM exclusion criteria may be based onThe first stage test results are adjusted); 3. Severe severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, patients with malignant tumors; 4. The following laboratory inspection values or inspection values are abnormal: 1. Blood routine: Platelet (PLT) \< 75×109/L , Hemoglobin (HGB) \< 90 g / L; 2. Prothrombin activity was \< 40%, and prothrombin time (PT) was prolonged for \> 5s; 3. Left ventricular ejection fraction (LVEF) was \< 50%; 5. Allergic or intolerant to trial drugs, or allergic constitution; 6. Subjects were unable to express their own complaints, such as psychosis and severe neurosis; 7. Poor compliance and they cannot collaborate; 8. Pregnant women, lactating women, or women of childbearing age preparing to conceive; 9. Participating in other clinical trials within 3 months; 10. Patients who have used ursodeoxycholic acid other than adenosine methionine within 3 days before randomization; 11. The investigator considered any circumstances unsuitable for inclusion. The third stage: Subjects meeting one of the following conditions will not be included in the trial: 1. Those who have completed the liver transplantation, or plan to do it within 1 month; 2. Severe grade 3 ascites or refractory ascites; 3. Patients with associated grade 3 hepatic encephalopathy; 4. Those who had received artificial liver treatment within 1 week prior to screening period; 5. Patients with serious basic diseases, such as respiratory system, digestive system, circulatory system, endocrine system and other diseases and malignant tumors, and serious infected persons with uncontrollable drugs; 6. The results of gastroscopy or imaging (abdominal B ultrasound, CT or MRI) within 1 month before the screening period or during the screening period, that indicate the risk of severe varicose veins with bleeding; 7. The following acute kidney injury (AKI) patients are defined as meeting one of the following conditions: 1. Serum creatinine (Scr) was increased by 26.5 μmol/L (0.3 mg/dL, 1 mg/dL=88.4 μ mol / L) within 48 hous; 2. the Scr increased by more than 1.5 times or more than the base value within 7 days ; 3. Urinary volume was decreased (\<0.5 ml/kg / h) and lasted for more than 6 hours; 8. Allergic or intolerant to trial drugs, or allergic constitution; 9. Subjects were unable to express their own complaints, such as psychosis and severe neurosis; 10. Poor compliance and they cannot collaborate; 11. Pregnant women, lactating women, or women of childbearing age preparing to conceive; 12. Participating in other clinical trials within 3 months; 13. The investigator considered any circumstances unsuitable for inclusion. -

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2024-02-20