Liver fibrosis
Conditions
Interventions
TB001:TB001
Placebo:Placebo
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Healthy male or female subjects aged 18-55; 3. BMI within 18.0-28.0 kg/m2; 4. The subject must be medically assessed by the investigator to be in good physical and mental health; 5. Use an effective contraceptive method during the study period and 120 days after the last study medication.
Exclusion criteria
Exclusion criteria: 1. The subject has any prior clinical serious disease of any system; 2. Known or suspected allergy to the study drug or any of its ingredients; 3. Severe infection, severe trauma, or major surgical operation within 3 months before the first administration; 4. A history of recurrent or chronic infection within 6 months prior to first administration; 5. Have used any prescription drugs, nonprescription drugs and Chinese herbal medicines within 2 weeks prior to the first administration, and plan to use non-study drugs during the study period. Positive substance abuse screening during screening; 6. Test positive for either hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIVAb) or treponema pallidum antibody (TPAb); 7. Smoked more than 10 cigarettes per day on average within 3 months before the first administration; Should not stop using any tobacco products during the study period; 8. Average alcohol intake of more than 15g per day during the first 3 months of administration; Should not stop using any alcohol products during the study period; 9. Those who consumed tea, coffee, and/or caffeine-rich beverages within 3 days prior to initial administration, or who could not stop consuming such beverages during the study period; Those who have special dietary requirements and cannot follow a uniform diet; 10. Pregnant or lactating women; 11. The investigator considers that the subject is not suitable to participate in the study under other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters ;Potential pharmacodynamics characteristics; | — |
Countries
China
Contacts
Public ContactMing Liu
Shenzhen Turier Biotech Co., Ltd.
Outcome results
None listed