Ulcerative Colitis
Conditions
Interventions
6.25 mg dosage group:Single oral dose of 6.25 mg (1/4 tablet) H021 tablet in the fasting state.
12.5 mg dosage group:8 subjects received a single oral dose of 12.5 mg (1/2 tablet) of H021 tablet, and 2 subjects received a single oral dose of 12.5 mg (1/2 tablet) of placebo in the fasting state.
25 mg dosage group:8 subjects received a single oral dose of 25 mg (1 tablet) of H021 tablet, and 2 subjects received a single oral dose of 25 mg (1 tablet) of placebo in the fasting state.
50 mg dosage group:8 subjects received a single oral dose of 50 mg (2 tablets) of H021 tablets, and 2 subjects received a single oral dose of 50 mg (2 tablets) of placebo in the fasting state.
100 mg dosage group:8 subjects received a single oral dose of 100 mg (4 tablets) of H021 tablets, and 2 subjects received a single oral dose of 100 mg (4 tablets) of placebo in the fasting state.
Fasting-postprandial group:Subjects received a single oral dose of 25 mg (1 tablet) H021 tablet in the fasting and postprandial state in the two cycles separately.
Postprandial-fasting group:Subjects received a single oral dose of 25 mg (1 tablet) H021 tablet in the postprandial and fasting state in the two cycles separately.
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. healthy adult subjects aged 18~55 years old (including 18 and 55 years old) of both sexes (healthy means that the results of medical history, physical and vital signs examination, chest X-ray (orthopantomogram), laboratory tests and 12-lead electrocardiogram are normal or abnormal but not clinically significant in the judgment of the investigator); 2. weight =50.0kg for men and =45.0kg for women and body mass index (BMI): 19.0~26.0kg/m2 (including 19.0 and 26.0, BMI = weight (kg)/height2 (m2), retaining 1 decimal place); 3. Subjects voluntarily signed the informed consent form; 4. subjects promise to have no birth plan, no sperm or egg donation plan, and to take appropriate contraceptive measures to avoid pregnancy by themselves or their partners from the time of signing the informed consent to 6 months after the last administration of the test drug; 5. Subjects have a good lifestyle and are able to maintain good communication with investigators and comply with the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Subjects have a history of neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, skeletal or other systemic diseases, infectious diseases, or diseases of vital organs that, in the opinion of the investigator, would compromise the safety of subjects; 2. Subjects have a history of clinically significant food or drug allergies or a history of atopic allergic disease (e.g., asthma, urticaria, eczematous dermatitis, etc.) or a known hypersensitivity to the components and excipients of the test drug; 3. Subjects who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the study period,or have any disease or history of disease that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, or any condition that may pose a hazard to the subject, such as: (1)Subjects with inflammatory bowel disease, gastric ulcers, duodenal ulcers, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities; (2) Subjects have a prior history of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric division described or gastric pouch banding, cholecystectomy, with the exception of appendicitis surgery and prolapse); (3)Subjects have liver disease or have a history or evidence of hepatic insufficiency (e.g., AST, ALT, or total bilirubin > 1.5 times ULN) at screening; (4) Subjects have renal disease or have a history or evidence of renal insufficiency at screening, as evidenced by clinically significant creatinine abnormalities or abnormal urine composition (e.g., proteinuria, etc.); (5) Subjects have urinary tract obstruction or difficulty emptying urine at screening; 4. Subjects who have consumed excessive amounts (more than 8 cups a day on average, 1 cup = 250 mL) of tea, coffee, or caffeinated beverages in the 3 months prior to screening; or who have ingested tea or any caffeine-containing foods or beverages (e.g., coffee, chocolate, etc.) in the 48 h prior to dosing; 5. Subjects smoked more than 5 cigarettes per day on average in the 3 months prior to screening or were unable to stop smoking for the entire duration of the trial; 6. Subjects have consumed alcohol on a regular basis during the 3 months prior to screening, i.e., an average of more than 2 units of alcohol per day (1 unit = 360mL of beer or 45mL of 40% alcohol by volume spirits or 150mL of wine) or are unable to stop consuming alcohol during the test period; or have a positive breath test result for alcohol; 7. Subjects have donated blood or lost blood=400mL (except for physiologic blood loss in women) within 3 months prior to screening, or plan to donate blood during the period of medication administration through 3 months after discontinuation of medication; 8. Subjects who have taken drugs within 3 months or have a history of substance abuse/dependence within 12 months prior to screening or have a positive urine drug screen at screening; 9. Subjects who have been vaccinated within 3 months prior to screening and those who plan to be vaccinated within 3 months of the end of the trial; 10. Subjects have participated in a clinical trial of another drug or device within 3 months prior to screening and has been treated with the trial drug or device; 11. Subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Single-dose study: safety indicators;Food effect study: PK parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single-dose study:PK parameters;Single-dose study:PD parameters;Food effect study: safety indicators; | — |
Countries
China
Contacts
Public ContactJie Pan
The Second Affiliated Hospital of Soochow University
Outcome results
None listed