atopic dermatitis
Conditions
Interventions
Single administration test group 1:MDI-1228 dose 70 mg
Single administration control group 1:Placebo dose 70mg
Single administration test group 2:MDI-1228 dose 140 mg
Single administration control group 2:Placebo dose 140mg
Single administration test group 3:MDI-1228 dose 280 mg
Single administration control group 3:Placebo dose 280mg
Single administration test group 4:MDI-1228 dose 420 mg
Single administration control group 4:Placebo dose 420mg
Multiple administration test group 1:MDI-1228 dose 70mg (14g)
Multiple administration control group 1:Placebo (14g)
Multiple administration test group 2:MDI-1228 dose 105mg(14g)
Multiple administration control group 2:Placebo (14g)
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy males or females aged 18-45 (including boundary values); 2.Body weight >=50 kg (male), body weight >=45 kg (female), body mass index (BMI= weight [kg]/ height [m2]) between 19 and 27 kg/m2 (including boundary value); 3.The skin of the whole body has no ulceration, injury, sunburn, redness, swelling, rash, or abnormal fever, and agree to shave the hair on the skin of the administration site (if any); 4. Fertile men and women of reproductive age are willing to use effective contraceptive measures, including abstinence, condoms, and intrauterine devices, from signing informed consent to 3 months after the last administration of MDI-1228_Mesylate gel. Blood pregnancy test results of women of childbearing age during screening period must be negative; 5. The subject can communicate well with the researcher, understand and comply with the requirements of the study; 6. The subjects voluntarily participated in the clinical trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Current or past skin disease that may affect the evaluation of the administration site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevus, other skin lesions, a history of skin cancer, or a skin disease that may affect the safety evaluation of the test drug; 2. Skin lesions or abnormalities in the target application area, such as tattoos, birthmarks, skin scars, skin perforation or skin thinning, which may affect the evaluation of the drug administration site; 3. History of using topical drugs, skin tanning products or other topical products in the target application area within 14 days before screening; 4. Current allergic diseases (including allergic dermatitis, allergic rhinitis and allergic asthma, allergic purpura, etc.),history of drug allergy (including allergy to penicillin and sulfonamides ), history of skin allergy (including but not limited to allergy to skin patch, and allergic dermatitis when touching metal, cosmetics and household items), vulnerable to allergies or allergic to the active ingredient or excipient of the investigational drug; 5. Current or past neurological, cardiovascular, blood and lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic and skeletal diseases or mental diseases, and abnormalities considered clinically not suitable for the study by the investigator ; 6. History of malignant tumor; 7. History of surgical procedure within 3 months prior to screening, or planned surgery during the study and within 1 month after all the planned study visits; 8. Abnormal results of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL) or serum creatinine 1.5 times greater than the upper limit of reference value (ULN) or other laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.) that are clinically significant; 9. Abnormal physical examination and vital signs (systolic blood pressure =140 mmHg, diastolic blood pressure =90 mmHg; Pulse rate 100 BPM), abnormal 12-lead ECG that will affect this study; 10. Difficulty in blood collection or intolerance to venipuncture, history of needle phobia and hematophobia; 11. Non-menstrual blood loss of >=400 mL (including trauma, blood collection, or blood donation) within 3 months prior to the trial, or receiving transfusion of any blood products, or planning to donate blood or blood components during the trial or within 3 months after the trial; 12. Those who smoked more than 5 cigarettes per day within 3 months before the trial and could not stop smoking during the whole trial period; 13. Those who have consumed more than 14 units of alcohol per week (1 unit ˜360 mL beer or 45 mL 40% spirits or 150 mL wine), or who are positive for alcohol breath test (breath alcohol >0.0 mg/100 mL), or who cannot abstain from alcohol during the test period, within 3 months prior to signing the informed consent; 14. Long-term excessive drinking of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup =200 mL); 15. Subjects who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or healthcare products within 2 weeks before the first dose (if the investigator determines that the time in between is longer than 5 half-life, the corresponding subjects can also be included in the study). 16. Inoculation of live vaccines, including but not limited to measles,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event, AE;Vital signs;physical examination;laboratory examination;blood examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-last;AUC0-inf;Cmin,ss;Cmax,ss;Tmax,ss;AUCss;accumulation factor; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital affiliated to Fudan University
Outcome results
None listed