nonalcoholic steatohepatitis
Conditions
Interventions
Group 1:single dose
Group 2:multiple doses
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 55 years (including 18 and 55 years old), no gender limit; 2. Body weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg/m^2 (including 19 kg/m^2 and 26 kg/m^2); 3. Physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (post-anterior), abdominal B-ultrasound, and important indicators of laboratory examinations are all normal or abnormal without clinical significance; 4. Agree to have no parenting plan and take reliable contraceptive measures during the research period and within 3 months after taking the drug, and avoid donating sperm or eggs; 5. Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are known to have a history of allergy, allergic disease or allergic constitution to the study drug and its similar drugs or any preparation ingredients; 2. There is any history or current disease that may affect the safety evaluation of the subject or the in vivo process of the research drug, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (except appendicitis surgery), etc.; 3. Blood donation or blood loss >= 400 mL within 3 months before study drug administration, or blood donation (including component blood donation) or blood loss >= 200 mL within 1 month before study drug administration; 4. Any drug that inhibits or induces liver drug metabolizing enzymes (such as inducersbarbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) within 30 days before the administration of the study drug; Inhibitorsserotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) or a monoamine oxidase inhibitor or a drug known to have monoamine oxidase inhibitory activity; or taking any prescription, over-the-counter, and herbal medicines other than the above-mentioned drugs within 14 days or 5 drug half-lives (whichever is longer) prior to study drug administration; 5. Those who have participated in drug clinical trials within 3 months before the administration of the study drug; 6. Current or former drug users, or those with positive drug abuse screening (screening items include: morphine, tetrahydrocannabinol acid, methamphetamine, MDMA, ketamine and cocaine); 7. Alcoholics or frequent drinkers within 3 months before the trial, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or positive alcohol breath test; 8. Smokers or those who smoked more than 10 cigarettes per day within 3 months before administration, or those who could not comply with the prohibition of smoking during the trial; 9. Those who are positive for the new coronavirus nucleic acid test (COVID-19), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody test, people with previous infection or latent infection with Mycobacterium tuberculosis (positive T cell test result for tuberculosis infection); 10. Pregnancy or lactation; 11. Those who have special requirements for diet and cannot comply with the unified diet; 12. QTcF>450 milliseconds (msec) for males and >470 milliseconds (msec) for females during screening; 13. Sitting systolic blood pressure >140 mmHg or 90 mmHg or 100 beats/min; 14. Glomerular filtration rate 1.5xULN; 16. Current infection (including local infection), or recent (within 1 week before administration) infection, cough or fever; or a history of repeated or chronic infection; 17. Those who have received a live vaccine (bacterial or viral) within 12 weeks before screening, or intend to receive any live vaccine during the study period or within 30 days after the last dose. For any vaccine (including the new coronavirus vaccine) vaccinated within 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;physical examination;12-lead electrocardiogram (ECG);laboratory examination; | — |
Countries
China
Contacts
Public ContactWei Fengrong
Yinuo (Zhejiang) Pharmaceutical Co., Ltd.
Outcome results
None listed