nonalcoholic steatohepatitis
Conditions
Interventions
Group 1:AP025 (50 mg/time) or placebo, once a week for 12 weeks.
Group 2:AP025 (50 mg/time) or placebo, once a week for 12 weeks. PK samples will not be collected.
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects should be able to understand and voluntarily sign written informed consent, which includes requirements related to drug dosing and collection of all study samples involved. 2. Men or women aged 18-65 years (including the threshold). 3. There is clinical evidence of fasting TG= 2.0mmol /L and = 5.6mmol /L in the 3 months before screening, and fasting TG= 2.0mmol /L and = 5.6mmol /L during screening. At the time of screening, no lipid-regulating drug was received or only a single lipid-regulating drug was received. 4. Body mass index (BMI) : 22.0~35.0 kg/m2 (including the critical value). 5. If receiving antidiabetic medication, consent is required to stop the medication at least until the end of the study (from 7 days before the first dose to the end of the study). 6. The subjects (including their partners) had no pregnancy plan from two weeks before screening to three months after the last study administration, and voluntarily adopted effective, non-drug contraception and had no sperm or egg donation plan; or the subject is infertile (surgically sterilized or menopausal).
Exclusion criteria
Exclusion criteria: 1. Those who have received any vaccine within 28 days before the first dose. 2. Have a history of tumor (whether cured or not, except basal cell carcinoma and carcinoma in situ). 3. Have a history of allergy to drugs, especially protein drugs or food. 4. Smokers who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the test period. 5. A history of alcohol abuse in the 3 months prior to screening (14 units of alcohol consumed per week: 1 unit ˜360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or not be able to stop taking any alcohol-containing products during the test, or test positive for alcohol. 6. Excessive consumption of tea, coffee or caffeinated beverages in the 3 months prior to screening (more than 8 cups of corresponding beverages per day, 1 cup is 250 mL), or consumption of any caffeinated food or beverage (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours prior to the first dosing of the study. 7. There is a history of drug abuse within 1 year before screening or a positive drug screen test during the trial period. 8. Diabetics with any of the following conditions: a) Type 1 diabetes, secondary diabetes, or specific types of diabetes. b) Fasting blood glucose > 11.1mmol /L (200 mg/dL). c) Evidence or history of diabetic complications with significant end-organ damage, such as proliferative retinopathy and/or macular edema, diabetic nephropathy, diabetic neuropathy. d) one or more episodes of severe hypoglycemia in the 6 months prior to taking the study drug, or a history of hypoglycemia with little or no knowledge of the symptoms of hypoglycemia. e) Take two or more antidiabetic drugs within 4 weeks prior to screening. f) Use insulin during screening. g) Known hemoglobiosis (alpha thalassemia), hemolytic anemia, sickle cell anemia, or a hemoglobin value 2.0×ULN; The estimated glomerular filtration rate (eGFR) was 450 ms for men and 470 ms for women. 13. Screening was hepatitis B Surface antigen (HBsAg) positive, hepatitis C antibody (HCV Ab) positive, human immunodeficiency virus (HIV) positive or serum T
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safe outcomes (TEAE, physical examination, vital signs, electrocardiogram, laboratory results); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome (Plasma concentration);PD outcome;Immunogenicity outcome (ADA/nAb); | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed