Graft-versus-host disease, alcoholic hepatitis, chronic and acute-on-chronic liver failure (ACLF)
Conditions
Interventions
Single - dose escalation of intravenous infusion in the 45 µg/kg group:F-652 is given as a single dose on Day 1.
Administration method:
IV infusion: The corresponding dose of F-652 is prepared in 10
Single - dose escalation of intravenous infusion in the 60 µg/kg group:F-652 is given as a single dose on Day 1.
Administration method:
IV infusion: The corresponding dose of F-652 is prepared in 10
Single - dose escalation of subcutaneous injection in the 120 µg/kg group:F-652 is given as a single dose on Day 1.
Administration method:
Subcutaneous injection: F-652 injection is administered su
Single - dose escalation of intravenous infusion in the 120 µg/kg group:F-652 is given as a single dose on Day 1.
Administration method:
IV infusion: The corresponding dose of F-652 is prepared in 1
for the 30 µg/kg, 60 µg/kg, 120 µg/kg, or higher dose groups, the corresponding dose of 5 mg/mL F-652 injection is administered subcutaneously in the abdomen.
Single - dose escalation of subcutaneous injection in the 2 µg/kg group:F-652 is given as a single dose on Day 1.
Administration method:
Subcutaneous injection: F-652 injection is administered subc
Single - dose escalation of intravenous infusion in the 240 µg/kg group:F-652 is given as a single dose on Day 1.
Administration method:
IV infusion: The corresponding dose of F-652 is prepared in 1
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-45, gender unlimited; 2.Body Mass Index (BMI) is between 18-25 kg/m²; for males, the weight is not less than 50 kg, and for females, it is not less than 45 kg; 3.Good physical health, with normal medical history and physical examination results, or abnormalities deemed clinically insignificant by the researcher; 4.Laboratory tests and urine tests are normal, or the abnormalities are judged by the researcher to be clinically insignificant; 5.Electrocardiogram and vital sign monitoring are normal, or the abnormalities are judged by the researcher to be clinically insignificant; 6.Subjects (including males) have no plans to have children from 2 weeks before screening to 6 months after the last administration of the study drug, and voluntarily take effective contraceptive measures; 7.The subject has signed the informed consent form and is able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1.Those with a history of major diseases in the heart, liver, kidneys, nervous system, respiratory system, blood, digestive system, immune system, or mental health, which are judged by researchers to be clinically significant and may confound the study results or affect the absorption, distribution, metabolism, or excretion of the drug; 2.Those who are suffering from skin exfoliation, eczema, or other clinically significant skin diseases as determined by the researcher at the time of screening; 3.Those with a history of malignant tumor diseases, or associated with other abnormal proliferative diseases (including benign tumors); 4.Those with a history of atopic dermatitis, asthma, urticaria, and other allergic diseases, or a history of drug allergy, severe allergic constitution, or known allergy to F-652-like proteins or their excipients and other components; 5.Those with a history of autoimmune diseases, such as psoriasis, rheumatoid arthritis, inflammatory bowel disease, etc.; 6.Those with underlying metabolic or cardiovascular and cerebrovascular diseases that require drug control; 7.Those with a positive result in any one of the tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antibody; 8.Individuals infected with active pulmonary tuberculosis; 9.Those with a history of drug abuse within the past year, or those who test positive for drug abuse during the screening period; 10.Those who have used prescription drugs or known drugs that interfere with metabolic enzymes within 14 days before screening; 11.Those who have used other drugs, including over-the-counter drugs, Chinese herbal medicines, and vitamins, within 7 days before administration; 12.Those who have participated in other clinical trials within 30 days before administration or within 5 half-lives of the drug; 13.Those who smoke more than 10 cigarettes per day, or who cannot quit smoking during the study period; 14.Those with a history of alcoholism or alcohol intoxication, or those who cannot abstain from alcohol during the study period; 15.Those with abnormal mental status or unable to understand this study and its possible impacts; 16.Those with expected poor compliance, such as those who are uncooperative, are expected to fail to follow up on time, or cannot complete the trial; 17.Those with positive blood pregnancy test results; 18.Other circumstances deemed by the researcher as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters;Pharmacodynamics (PD) parameters; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed