Psoriasis
Conditions
Interventions
SAD part:Single doses of HCXT-2001 40, 100, 200, 400, 800, 1000 mg/placebo, including 200 mg under fasting and fed conditions.
MAD part:Multiple doses of HCXT-2001 100 mg QW, tentative 200 mg QW, tentative 400 mg QW, tentative 20 mg QD, tentative 40 mg QD/placebo
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18 to 45 years inclusive at screening. 2. Male participants with body weight of at least 50 kg and female participants with body weight of at least 45 kg, with body mass index within 19.0 to 26.0 kg/m^2 inclusive. 3. Participants who are in good health based on medical history, vital signs, physical examination, laboratory tests, 12-lead ECG, chest examination and other examinations, with normal results or abnormalities considered not clinically significant by the investigator. 4. Participants who fully understand the study, voluntarily participate in the study, and have signed the informed consent form. 5. Participants and their partners have no fertility plan from 2 weeks before screening to 6 months after the last dose of study drug, agree to use one or more effective non-pharmacological contraceptive methods during this period, and have no sperm or egg donation plan.
Exclusion criteria
Exclusion criteria: 1. Participants with immune disease or a history of immune disease. 2. Female participants who are pregnant, have a positive blood pregnancy test, or are breastfeeding. 3. Participants with any disease or abnormality that is clinically significant or may interfere with study conduct or interpretation of study results, including but not limited to diseases of the nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, hematologic system, endocrine system, tumor, lung, immune system, psychiatric system, or cerebrovascular system. 4. Participants who, within 24 hours before admission, have smoked, consumed coffee, eaten methylxanthine-containing food, grapefruit, pomelo, bitter orange or related products, or performed strenuous exercise that may affect drug absorption, distribution, metabolism or excretion. 5. Participants with known allergy to the investigational drug or any of its components, or with a history of specific allergy, including drug allergy or food allergy. 6. Participants who have undergone surgery that may affect the study results, including but not limited to cholecystectomy or major gastrectomy, except minor surgery such as appendectomy or superficial lipoma resection. 7. Participants who have used any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 14 days before screening or within 5 half-lives before the first dose, whichever is longer, except when the investigator determines that it will not affect the study results. 8. Participants who have donated blood or experienced blood loss of more than 400 mL within 2 months before screening, received blood transfusion within 2 months before screening, or plan to donate blood during the study or within 60 days after the last dose. 9. Participants who have participated in any investigational drug or medical device clinical trial within 3 months before screening and received investigational drug or medical device intervention. 10. Participants with a history of alcohol abuse, or who consumed more than 14 units of alcohol per week within 6 months before screening, or who are unwilling to abstain from alcohol during the study, or who have a positive alcohol breath test at screening. 11. Participants with a history of smoking, or who smoked an average of at least 5 cigarettes per day within 3 months before screening, or who are unwilling to abstain from smoking during the study. 12. Participants with a history of drug abuse, use of illicit drugs within 3 months before screening, or a positive urine drug screen. 13. Participants with infection within 7 days before screening, including chronic or local infection, or with a history of recurrent infection and underlying disease predisposing to infection, or with a history of opportunistic infection. 14.Participants with any positive result for hepatitis B surface antigen, syphilis-specific antibody, hepatitis C antibody, or human immunodeficiency virus antibody. 15. Participants who have received any vaccine within 1 month before screening, or plan to receive any vaccine during the study or within 1 month after the end of the study. 16. Participants who, in the opinion of the investigator, have any other factor that may affect study results or interfere with participation in the entire clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity outcomes;Pharmacokinetic parameters (Cmax, Tmax, Cmin, Cavg, AUCtau,etc.)after once-daily multiple dosing;Pharmacokinetic parameters (Cmax, Tmax, Cmin, Cavg, AUCtau,etc.)after once-weekly multiple dosing;Pharmacokinetic parameters after single oral dosing;Exploratory pharmacodynamic outcomes;Food-effect pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed