inflammatory bowel disease
Conditions
Interventions
Group A:single oral dose (dose 1)
Group B:single oral dose (dose 2)
Group C:single oral dose (dose 3)
Group D:single oral dose (dose 4)
Group E:single oral dose (dose 5)
Group F:single oral dose (dose 6)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. A signed and dated written informed consent form (ICF) must be provided before any study-specific procedures are performed; 2. At the time of screening, healthy subjects aged 18-45 (including the upper and lower limits), both male and female; 3. At the time of screening, female weight >= 45 kg, male weight >= 50 kg, and the body mass index (BMI) is 19.0-26.0 kg/m2 (including upper and lower limits); 4. Physical examination, vital signs, electrocardiogram and laboratory tests, etc., the results are normal or the researchers judge that the abnormalities have no clinical significance; 5. The blood human chorionic gonadotropin (HCG) pregnancy test result of women of childbearing age is negative at the time of screening. The subjects and their sexual partners are willing to have no birth plan and voluntarily take effective contraceptive measures from 2 weeks before the screening to 6 months after the last dose of the study drug, and have no plan to donate sperm or eggs, and guarantee that they will be free from 2 weeks before the screening to the study period. Use one or more non-drug contraceptive measures in sexual life within 1 month after the last dose of the drug.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of cardiovascular system, blood system, digestive system, respiratory system, urinary system, nervous system, immune system and other diseases, and have clinical significance as judged by the investigator; 2. Those with a history of allergic diseases in the past, including allergies to drugs or food; 3. Previously suffered from clinically relevant immunosuppressive diseases, and used or planned to use systemic immunosuppressants or immunomodulatory drugs during the study or within 4 months before the first administration of the study drug; 4. Those who have a history of drug abuse within 6 months before screening, or who are positive for urine drug abuse screening during the screening period/baseline period; 5. Excessive drinking of more than 14 cups per week = 150 ml of wine, or 360 ml of beer, or 45 ml of spirits within 3 months before the screening, or a positive alcohol blood test during the screening period/baseline period; 6. The average daily smoking volume >= 5 cigarettes within 3 months before screening, or those who have difficulty quitting smoking during the study period; 7. Those who have been enrolled in other clinical trials and used drugs within 3 months before taking the study drug for the first time; 8. Within 14 days before screening or within 5 half-lives of the first study administration, whichever is longer. Except for taking any prescription drugs, non-prescription drugs, Chinese herbal medicines or vitamins, which the investigator judges will not affect the study results; 9. Physical examination, vital sign detection, 12-lead electrocardiogram, laboratory examination, etc., which are abnormal and have clinical significance as judged by the investigator; 10. There is active or latent infection at the time of screening; 11. Subjects who tested positive for hepatitis B surface antigen HepBsAg., hepatitis C antibody HCVAb., syphilis antibody or human immunodeficiency virus antibody HIVAb. during screening; 12. Pregnant or lactating female subjects; 13. Non-physiological blood loss >= 500 ml within 60 days before the first medication, including trauma, blood collection, and blood donation; non-physiological blood loss >= 50 ml within 14 days before the first medication, including trauma, blood collection, and blood donation; or planned during the trial or 30 days after the last medication Blood donors within days; 14. Those who have undergone major surgery within 60 days before taking the medicine for the first time, or have undergone any surgery within 28 days before taking the medicine for the first time; 15. Those who have had fever and other infection symptoms within 28 days before taking the medicine for the first time; 16. Those who tested positive for the new coronavirus during the screening period; 17. Those who have been vaccinated within 1 month before taking the medicine for the first time, or who plan to vaccinate during the trial or within 1 month after the end of the trial; 18. According to the investigator's judgment, there are other subjects who may affect the research results and interfere with their participation in the entire research process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fecal drug concentration;urine drug concentration;plasma drug concentration;plasma VNN1 activity;Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram;Physical examination; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed