Inflammatory Bowel Disease,IBD
Conditions
Interventions
300 mg group:3×100 mg/cycle
100 mg(BID) group:AC-101 tablets: 1×100 mg×2 times/day, Placebo:1 tablet ×2 times/day
200 mg(QD) group:AC-101 tablets: 2×100 mg×1 time/day
Placebo: 2 tablets x 1 time/day
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Before participating in any study-related activities, written informed consent must be signed, and subjects need to understand the nature and purpose of the trial, including potential risks and adverse reactions. (2) At the time of screening, subjects should be between 18 and 60 years of age (inclusive of the critical values), and the gender is not limited. (3) At the time of screening, the Body Mass Index (BMI) = weight (kg) / (height)^2 (m^2), with a BMI ranging from 19.0 to 28.0 kg/m^2 (inclusive of the critical values); male subjects should weigh >=50 kg, female subjects should weigh >=45 kg, and the weight of both male and female subjects should be <120 kg. (4) Vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.) should be normal or any abnormalities judged by the researcher to be clinically insignificant. (5) If the subject is female, she must meet the following criteria: a. Be infertile, which means having undergone surgical sterilization (at least 6 weeks before screening for hysterectomy/bilateral salpingectomy/bilateral oophorectomy) or being postmenopausal (defined as no menstruation for more than 12 months, excluding other medical reasons); or b. The subject and her partner are willing to have no plans for pregnancy from 2 weeks before screening until 6 months after the last administration of the study drug and voluntarily use effective contraceptive measures, with no plans for sperm or egg donation, and ensure the use of one or more non-pharmacological contraceptive methods during sexual activity from 2 weeks before screening until 1 month after the last administration of the study drug. (6) Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
Exclusion criteria: (1) A history of chronic diseases of the cardiovascular, respiratory, digestive, liver, urinary, hematological, endocrine, metabolic, immune, skin, or psychiatric and nervous systems, including any surgical procedures determined by the researcher to be clinically relevant within 3 months prior to screening or any history of acute diseases within 2 weeks prior to screening, and any abnormalities assessed by the researcher as clinically significant. (2) Use of any medication that inhibits or induces liver drug metabolism enzymes within 30 days before the screening period; consumption of foods or beverages containing substances that induce or inhibit liver metabolism enzymes (such as red wine, dragon fruit, mango, grapefruit, grapefruit juice, pomelo, star fruit, lime, lime jam, or other foods or beverages containing grapefruit, pomelo, star fruit, or lime) within 7 days before the start of the trial's drug administration; unwillingness or inability to guarantee the cessation of intake of any foods or beverages containing or metabolizing into caffeine or xanthine (such as coffee, tea, chocolate) or engaging in strenuous exercise from 48 hours before the first drug administration until the last pharmacokinetic blood sample collection; or special dietary requirements that prevent adherence to a uniform diet. (3) Subjects enrolled in the food effect study with dietary restrictions (such as lactose intolerance) or unable to consume a high-fat meal. (4) Sequelae of gastrointestinal, liver, kidney, or other known diseases that interfere with drug absorption, distribution, metabolism, or excretion. (5) Current treatment with antibiotics, antifungal drugs, antiparasitic drugs, or antiviral drugs for an infection. (6) Any history of malignant tumor diseases. (7) Use of or planned use of systemic immunosuppressants (including but not limited to corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulatory drugs (including but not limited to interferon) during the study period or 4 months before the first drug administration; use of any prescription, over-the-counter, herbal, or health supplements within 14 days before the study drug administration (Note: Use of less than 2 g/day of acetaminophen is allowed 48 hours before administration); if the half-life of the previously used drug is long, the required time interval before the first administration of the study drug is at least 5 half-lives of that drug. (8) Serum creatinine values exceeding the upper limit of normal or estimated glomerular filtration rate (eGFR), eGFR 450 msec for males, >470 msec for females. (10) Positive results for hepatitis B surface antigen, hepatitis C (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or syphilis treponemal antibodies. (11) Alcohol consumption exceeding 14 units per week in the 3 months before screening (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine); or positive results for blood alcohol testing before randomization; or inability to abstain from alcohol 48 hours before the first drug administration and during the trial. (12) Smoking more than 5 cigarettes per day or habitual use of nicotine-containing products, smoking (including tobacco, e-cigarettes, and cannabis) within 1 month before the first study drug administration; or inability to stop using any tobacco products 48 hours before the first drug admi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Vital signs;Physical Examination;Laboratory tests ;12-lead ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;Tlag;Cmax;AUC0-t;AUC0-8;t1/2;CL/F;Vd/F ; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed