Psoriasis vulgaris
Conditions
Interventions
SAD Study (Part I):The SAD study is planned to be grouped in 6 doses in the range of 2.5 - 200 mg: 2.5, 7.5, 25, 75, 150, 200 mg. Eligible healthy adult subjects will be assigned to one of 6 ascending
MAD Study (Part II):According to the results of the Part-1 SAD study, combined with the data of the non-clinical efficacy study, 3 safe and expected effective doses were selected for the MAD safety, t
FE Studies (Part III):Study participants were randomly assigned to 2 cohorts to receive dosing after fasting or high-fat meals, respectively. When administering after meals, a high-fat breakfast shoul
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study, sign the informed consent form, be able to communicate well with the researcher, and understand and comply with the requirements and restrictions of this study; 2. Age 18 - 55 years old (including the boundary value, subject to the day of signing the informed consent), male and female; 3. Body mass index (BMI) within the range of 18.0 - 28.0 kg/m^2 (including boundary value) at screening, and weight > = 50 kg for males and > for females=45 kg; 4. No active or latent or previous evidence of Mycobacterium tuberculosis (TB) infection at screening, negative ?-interferon release test (IGRA) and chest X-ray (anteroposterior); 5. Physical examination, vital signs examination [reference value range (including boundary value): systolic blood pressure 140 - 90 mmHg, diastolic blood pressure 60 - 90 mmHg, pulse 50 - 100 bpm, body temperature (ear temperature) 35.8-37.2 °C], laboratory examination, 12-lead heart 5) electrogram and other auxiliary examination results are normal or judged by the investigator to be abnormal and not clinically significant; 6. Volunteers of childbearing potential have no pregnancy or sperm donation plan from the date of signing the informed consent form to 3 months after the last dose of study drug, and must comply with the relevant regulations of contraception during this period (see Appendix 1), must agree to take at least one highly effective non-hormonal contraceptive method, or the male partner has been sterilized at least 6 months before the screening visit, etc.
Exclusion criteria
Exclusion criteria: History of allergies 1. Those who are allergic to the active ingredients of the drug or their excipients in this study or contraindicated in use; 2. Have a significant history of multiple and/or severe allergies, including food allergies (Note: Participants with seasonal allergies may be allowed to participate, except for those with persistent symptoms). Medical history/medical condition 3. History of depression or post-traumatic stress disorder within 2 years prior to the screening visit; or have suicidal behavior or suicidal tendencies; or suicidal tendencies judged by the investigator (psychiatrist can be asked for evaluation if necessary), which may increase the risk of participating in the study, and is not suitable for participation in the study according to the judgment of the investigator; 4. Severe infectious diseases (if hospitalization or parenteral antibiotic therapy or opportunistic infections are required) within 6 months prior to screening, or a history of chronic or recurrent infectious diseases; 5. Within 3 months prior to screening, with symptomatic herpes zoster or herpes simplex; 6. Trauma or major surgical surgery within 3 months prior to screening, or surgery that may significantly affect the safety evaluation, or planned abdominal surgery during the course of the study; 7. History of infection and/or fever within 7 days prior to screening; 8. Previous lymphoproliferative disorders; 9. First-degree relatives with hereditary immunodeficiency diseases; 10. Previous history of venous thromboembolism (VTE) or coagulation dysfunction; 11. Has a history or current condition of other significant metabolic, infectious or cardiovascular, gastrointestinal, hepatic, renal/urinary, respiratory, endocrine, hematological, immunologic, neurological, reproductive system, dermatologic, malignant tumors (except basal cell carcinoma of the skin and cervical cancer in situ that have been resected and no evidence of recurrence) or psychiatric illness requiring medication and/or other treatment, including dietary restriction and physical therapy, which in the opinion of the investigator is not suitable for participation in this study; 12. Any previous condition that may affect drug absorption (e.g., gastric banding/gastrectomy, cholecystectomy, bowel resection) and/or duodenal disease (i.e., celiac disease) (except for appendectomy); 13. Previous or current presence of the following cardiac risk factors: a. Torsades de pointes or its risk factors, including use of drugs with delayed cardiac repolarization, hypokalemia, hypomagnesemia, and history of heart failure, bradycardia, cardiomyopathy, long QT syndrome b. 12-lead ECG measured in the supine position at rest for at least 10 minutes, resulting in a corrected QTcF interval of > 450 msec [corrected by Fridericia's formula, QTcF = QT (RR.-1/3) c. Orthostatic hypotension, unexplained syncope, myocardial infarction, angina, pulmonary congestion, and arrhythmias such as QT interval prolongation or conduction abnormalities, sick sinus syndrome and second- or third-degree atrioventricular block, family or personal history of A-S syndrome or Brugada syndrome Prior/concomitant therapy 14. Received vaccination within 6 weeks prior to study dosing, or planned to receive vaccination at any time during the treatment period or within 8 weeks after study completion, or, will have frequent contact with people vaccinated with live virus or live attenuated virus vaccine within 2 months after the end o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part-1 SAD & Part-2 MAD:To evaluate the safety and tolerability of single or multiple oral doses of CMS-D001;Part-3: FE: To assess the effects of food on exposure to CMS-D001 in a single oral dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Part-1 SAD & Part-2 MAD:To evaluate the pharmacokinetic (PK) profile of single or multiple oral doses of CMS-D001;Part-3: FE:To assess the safety and tolerability of single oral CMSD001 in fasting or postprandial conditions; | — |
Countries
China
Contacts
Public ContactZhaolin Huang
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Outcome results
None listed