InflammatoryBowelDisease,IBD
Conditions
Interventions
Control group:Placebo
Sponsors
Nanjing First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants must voluntarily join this study, sign the informed consent form in person, and be capable of completing all study-related procedures and visits. 2. At the time of screening, participants must be aged 18 to 45 years (inclusive), with no gender restrictions. 3. Body Mass Index (BMI) should be between 18.0 and 26.0 kg/m^2 (inclusive); male participants' weight should be >= 50 kg, and female participants' weight should be >= 45 kg. 4. Female subjects must meet at least one of the following conditions: a. Women of Childbearing Potential (WOCBP) must have negative results confirmed by serum pregnancy tests at the time of screening and before the first administration, and agree to take effective contraceptive measures throughout the study period and for at least 3 months after administration; b. Premenopausal women who meet one of these conditions: i. Premenopausal women who have undergone hysterectomy and have medical records; ii. Premenopausal women who have undergone bilateral salpingectomy and have medical records; iii. Premenopausal women who have undergone bilateral oophorectomy and have medical records; iv. Preferred or daily abstinent subjects c. Postmenopausal women (who have been absent for 12 months or more without other biological or physiological reasons). 5. Male subjects must meet at least one of the following conditions: a. Men who have had sexual intercourse with WOCBP must agree to take effective contraceptive measures throughout the study period and for at least 3 months after administration. Furthermore, male subjects had no sperm donation plans during this period. b. Men who have undergone vasectomy are exempt from contraceptive requirements. Researchers should emphasize the importance of contraception and the possible effects of unintended pregnancies to WOCBP subjects and male subjects who have sexual activity with WOCBP.
Exclusion criteria
Exclusion criteria: 1. Those with a history of allergy to any drugs and/or foods or with an allergic constitution; 2. Those with a history of or currently suffering from abnormalities in the musculoskeletal system, nervous system, mental system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, reproductive system, or immune system, and judged by the researcher to affect the current study assessment; 3. Those with abnormal results in vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, 12-lead electrocardiogram, and ultrasound examination during the screening period and judged by the researcher to have clinical significance; 4. There is a history of hepatotoxic reactions after medication. 5. Those with a history of or currently suffering from any gastrointestinal diseases that may affect drug pharmacokinetics (such as history of gastrectomy or cholecystectomy) (except appendectomy); 6. Those who have undergone major surgery within 4 weeks before the first dose; 7. Those with a history of or currently suffering from malignant tumors; 8. Those with a documented history of congenital long QT syndrome, and/or a corrected QT interval (Fridericia formula) of >450 ms for men and >460 ms for women at screening or the first hospitalization examination; 9. Those who have donated blood or lost more than 100 mL of blood within 2 months before the first dose, or donated blood or lost more than 1.5 L (for male subjects) / 1.0 L (for female subjects) within 10 months before the first dose (except during the female menstrual period); 10. Those who cannot tolerate venipuncture and/or have difficulty in blood collection; 11. Those with special dietary requirements and unable to follow a unified diet or have difficulty in swallowing; 12. Those who have smoked >= 3 cigarettes per day within 3 months before screening; those with a positive result in the smoke test at the time of hospitalization examination; 13. Those with a history of drug or drug abuse within 5 years before screening; those with positive results in the drug screening test (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, cocaine, 3,4-methylenedioxymethamphetamine) at screening or the time of hospitalization examination; 14. Those who have consumed more than 24 units of alcohol per week within 3 months before screening; those who cannot abstain from alcohol during the trial; those with a positive result in the alcohol breath test at the time of hospitalization examination (>0 mg/100 mL); 15. Those who consume food or beverages containing caffeine or xanthine within 72 hours before the first administration; 16. Within 14 days before the first administration until the end of the trial, consume known foods/dietary supplements that can regulate CYP enzyme activity (such as eating pitaya, mango, grapefruit/grapefruit, star fruit, blood orange and/or foods or beverages prepared from them); 17. People with lactose intolerance (those who have experienced diarrhea after drinking milk); 18. Positive test results of infectious disease screening during screening, including hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody (TPAb); 19. Any prescription drugs, over-the-counter drugs, any vitamin medicines or health supplements, herbs were used within 28 days prior to the first administration, except for the medications known and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abnormal changes from baseline in vital signs (blood pressure, respiratory rate, pulse rate and forehead temperature), physical examination, laboratory tests, electrocardiogram (ECG) tests, etc., adverse events, serious adverse events and their incidence rates, maximum tolerated dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters and PD parameters; | — |
Countries
China
Contacts
Public ContactHongwei Fang
Nanjing First Hospital
Outcome results
None listed