Psoriasis
Conditions
Interventions
Single Dose Group:Orally administration of AC-201 tablets (5 to 200 mg) or placebo once under fasting condition.
Food Effect Study:Six of these subjects completed a single dose under fasting condition in the first cycle and, after a 3-day washout period, completed a single dose with a high-fat meal in the secon
Multiple dose group:Three dose groups: 15 mg (qd), 15 mg (bid) and 50 mg (qd) dose groups were administered for 5 consecutive day.
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be signed prior to any trial-related activity and the characteristic and purpose of the trial, including possible risks and adverse reactions, must be well understood; 2. Those who aged between 18 and 60 years old (inclusive) at screening, male or female; 3. Male subjects weighing = 50 kg, female subjects weighing = 45 kg and their BMI between 19.0 ~ 28.0 kg/m2 (including the threshold value) at screening; 4. Vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (routine blood, urine, blood biochemistry, coagulation function, etc.) are normal or assessed by the investigator as abnormal without clinical significance; 5. In the case of female subjects must meet the following criteria: a. no childbearing potential, i.e., surgically sterilized (hysterectomy/bilateral salpingo-oophorectomy/bilateral salpingo-oophorectomy at least 6 weeks prior to screening) or menopausal (menopausal is defined as the absence of menstruation for a period of more than 12 months and other medical reasons are ruled out); or b. in the case of females of childbearing potential, the test medication must have been administered to the female at the time of screening (blood test) and at the time of the first test drug (D-1) pregnancy test negative at screening (blood test) and prior to administration of the first dose of the test drug, and must agree to be free of childbearing and egg donation and to voluntarily use effective non-pharmacological contraception for at least 3 months from the time of signing of the Informed Consent Form to the date of the last administration of the test drug; or, in the case of a male subject who has not been surgically sterilized, must agree to be free of childbearing and sperm donation and voluntarily use effective non-pharmacological contraception for at least 3 months from the time of signing of the Informed Consent Form to the date of the last administration of the test drug; and Be willing to use effective non-pharmacological contraception; 6. Be willing and able to undergo all trial evaluations and comply with the protocol schedule and restrictions.
Exclusion criteria
Exclusion criteria: 1. A history of chronic disease of the cardiovascular, respiratory, gastrointestinal, hepatic, urologic, hematologic, endocrine, metabolic, immunologic, dermatologic, or psychoneurologic systems, including surgery within 3 months prior to screening as determined by the investigator to be clinically relevant, or any history of acute illness within 2 weeks prior to screening that is assessed by the investigator to be clinically significant as an abnormality; 2. Use of any drug that inhibits or induces hepatic drug-metabolizing enzymes within 30 days prior to screening; consumption of food or beverages containing foods or beverages (e.g., grapefruit, etc.) that induce or inhibit hepatic drug-metabolizing enzymes within 7 days prior to the start of trial dosing; and disagreement or inability to ensure that ingestion of any food or beverage (e.g., coffee, tea, tea, etc.) that contains or that is metabolized to produce caffeine or xanthines will be discontinued from the period of 48 h prior to the first dose of the trial to the time of the last pharmacokinetic blood sample collection. 3. Subjects enrolled in the Food Effect Group have dietary restrictions (e.g., lactose intolerance) or are unable to consume high-fat meals; 4. Those with sequelae of gastrointestinal, hepatic, renal, or other disorders known to interfere with drug absorption, distribution, metabolism, or excretion; 5. Those with current infections requiring treatment with antibiotics, antifungals, antiparasites, or antivirals; 6. Those with a history of any malignant disease; 7. Use 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 trial or within 4 months prior to the first administration of the test drug; use of any prescription, over-the-counter, herbal, or nutraceutical medication within 14 days prior to the use of the test drug (NOTE: use of 450 msec in men and >470 msec in women; 10. Those who have a positive test for any of the Hepatitis B Surface Antigen, Hepatitis C Antibody, Human Immunodeficiency Virus Antibody, or Syphilis Spirochete Antibody; 11. Drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine) in the 3 months prior to screening; or having a positive blood alcohol test result before randomization; 12. Smoking greater than 5 cigarettes per day or habitual use of nicotine-containing products in the 3 months prior to screening, and smoking (including tobacco, e-cigarettes, and marijuana) in the 1 month prior to the first administration of the trial drug; 13. Those who have a history of substance abuse (including repeated, heavy use of all types of narcotic drugs and psychotropic substances for non-medical purposes) or a positive drug screening (including: morphine, methamphetamine, ketamine, ecstasy, tetrahydrocannabinolic acid, and cocaine, etc.) in the 3 months prior to scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome (Plasma concentration); | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed