F573 for Injection for the Treatment of Liver Injury/Failure

NCT05689645 | Recruiting Phase 2

• 1 other identifier: KDN-F573-202202
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 10

Brief Summary

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), intrahepatic cholestatic liver injury, etc.).

Conditions

Acute Liver Failure; Acute-On-Chronic Liver Failure

Keywords

F573 for injection Liver Injury/Failure

Outcome Measures

Primary Outcomes (14)

• Adverse events (AE), serious adverse events (SAE)

  to record Adverse events and serious adverse events in the trial

  7 days of administration in the first stage and 14 days of administration in the second stage

• Adverse events (AE), serious adverse events (SAE)

  to record Adverse events and serious adverse events in the trial

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• clinical laboratory tests ：blood routine

  blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.

  7 days of administration in the first stage and 14 days of administration in the second stage

• clinical laboratory tests ：blood routine

  blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• clinical laboratory tests ：blood biochemistry

  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.

  7 days of administration in the first stage and 14 days of administration in the second stage

• clinical laboratory tests ：blood biochemistry

  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.

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• clinical laboratory tests : urine routine

  urine routine report contains the following values: GLU,PRO,RBC,WBC.

  7 days of administration in the first stage and 14 days of administration in the second stage

• clinical laboratory tests : urine routine

  urine routine report contains the following values: GLU,PRO,RBC,WBC.

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• clinical laboratory tests ：blood coagulation function

  blood coagulation function report contains the following values: TT, APTT, PT, INR.

  7 days of administration in the first stage and 14 days of administration in the second stage

• clinical laboratory tests ：blood coagulation function

  blood coagulation function report contains the following values: TT, APTT, PT, INR.

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• 12-lead electrocardiogram (ECG)

  12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.

  7 days of administration in the first stage and 14 days of administration in the second stage

• 12-lead electrocardiogram (ECG)

  12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• All-cause mortality

  All-cause mortality within 28 days after completion of dosing.

  28 days after completion of dosing in the third stage

• All-cause mortality

  All-cause mortality within 90 days after completion of dosing.

  90 days after completion of dosing in the third stage

Secondary Outcomes (91)

• Basin alanine aminotransferase (ALT)

  after 7 days of administration in the first and second stages

• Basin alanine aminotransferase (ALT)

  after 14 days of administration in the second stages

• Basin alanine aminotransferase (ALT)

  followed up for 28 days in the first stage and followed up for 14 days in the second stage

• peak concentration (Cmax)

  12 hours after administration in the first and second stages

• Peak-reaching time (Tmax)

  12 hours after administration in the first and second stages

Study Arms (2)

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

Drug: F573 for injection

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.

Drug: Sterilizing water for injection

Interventions

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 .

F573 for injection groups

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.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• （1）The first stage:
• Participants who meet all of the following criteria will be enrolled in the study:
• Age ≥18 and ≤60 years old, gender is not limited;
• Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the "Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)"). Screening patients with CHB may provide etiological (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.
• Serum ALT: 2\~ 10× upper limit of normal (ULN), TBil: \<5×ULN;
• DILI patients: the abnormal duration of liver biochemical indexes \[ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time\] does not exceed 90 days;
• The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;
• Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.
• (2)The second stage:
• Subjects meeting all of the following criteria will be included in the study:
• Age ≥ 18 and ≤ 65 years old, with no gender restrictions;
• According to the "Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition)", patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;
• Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT \> 3 times the upper limit of normal (ULN), and TBil \> 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;
• Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil \> 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L); ② ALP \> 1.5 times the ULN; ③ALT\>1×ULN;
• The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;

You may not qualify if:

• The first stage:
• Subjects meeting one of the following conditions will not be included in the trial:
• According to the investigator's judgment, the subjects were patients with cholestatic liver injury;
• Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;
• Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;
• There are the following laboratory test values or abnormal test values:
• Blood routine: platelet (PLT) \<75× 109/L, hemoglobin (HGB) \<90 g/L;
• Prothrombin activity \<40%, prothrombin time (PT) extended \>5 s;
• Left ventricular ejection fraction (LVEF) \<50%;
• Allergic or intolerant to the investigational drug, or allergic;
• The subject is unable to express his main complaint, such as mental illness and severe neurosis;
• Poor compliance can not partner;
• Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
• Participants in other clinical trials within 3 months;
• Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (10)

Beijing You 'an Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Qingyuan People's Hospital (Sixth Affiliated Hospital of Guangzhou Medical University)

Qingyuan, Guangdong, China

RECRUITING

Shiyan City Taihe Hospital

Shiyan, Hubei, China

RECRUITING

Hunan Medical College General Hospital (formerly Huaihua City First People's Hospital)

Huaihua, Hunan, China

RECRUITING

Pingxiang Second People's Hospital

Pingxiang, Jiangxi P, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

The Affiliated Hospital of Binzhou Medical University

Binzhou, Shandong, China

RECRUITING

Heze Municipal Hospital

Heze, Shandong, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Liver Failure, Acute; Acute-On-Chronic Liver Failure

Interventions

Injections

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

ling zhang, Dr

CONTACT

13501209210; zhangling@bjcontinent.com

junqi niu, Dr

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 19, 2023
• Study Start: March 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)