Atopic Dermatitis
Conditions
Interventions
Group A:Single administration of HY-07170702 Ointment (concentration 1) , coating area: 10% BSA
Group B:HY-07170702 Ointment (concentration 1)/placebo:Day1-9 BID,Day10 QD
coating area: 20% BSA
Group C:HY-07170702 Ointment (concentration 2)/placebo:Day1-9 BID,Day10 QD
Group D:HY-07170702 Ointment (concentration 2)/placebo:Day1-9 BID,Day10 QD
coating area: 30% BSA
Group E:HY-07170702 Ointment (concentration 2)/placebo:Day1-9 BID,Day10 QD
coating area: 40% BSA
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Adult male or female subjects aged 18-45 years old (including threshold values); 2. Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg, with a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including threshold values), and body mass index (BMI) = body weight (kg)/height2 (m2); 3. Vital signs, physical examination, laboratory tests, electrocardiogram and other test results of subjects in the screening period are normal or abnormal without clinical significance as determined by the investigator; 4. Subjects commit to have no birth plan, no sperm donation plan and voluntarily use non-pharmacological contraception (pharmacological contraception includes local contraceptives such as spermicides, etc.) from 14 days prior to the screening to 3 months after the last dose; 5. Those who are fully understand the content, process and possible adverse reactions of the trial, and voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of clinically significant cardiac, hepatic, neurological, respiratory, hematologic, gastrointestinal, immunologic, renal, or psychiatric disorders that, in the opinion of the investigator, may confound the results of the study or interfere with the absorption, distribution, metabolism, and excretion of the medication, or that, in the investigator's judgment, are clinically significant; 2. Those who have a history of immune disorders including, but not limited to, rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, etc; 3. Those who are suspected hypersensitivity or allergy to the study drug or any component of the study drug; 4. In the opinion of the investigator, the subject has skin lesions, tattoos, scars, acne, or other abnormalities that may interfere with the evaluation of the site of administration of the study drug; 5. Those who has undergone surgical procedures within 3 months prior to screening or who plans to undergo surgical procedures during the study; 6. Those who have taken any medications or supplements (including herbal remedies) within 14 days prior to screening; 7. Those who have received any vaccine within 1 month prior to screening or who require a vaccine during the study period (including within 30 days of the last dose of study drug); 8. Those who use topical skin medications at the drug administration site within 21 days prior to dosing, or use skin tanning products (e.g., fast-acting tanning lotion) within 14 days prior to dosing, or use any topical skin product within 24 hours prior to dosing; 9. Those who use any drug that inhibits or induces hepatic metabolism of a drug (e.g.,Inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; depressants-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines etc.) within 30 days prior to screening; 10. Those who have participated in any clinical trial and taking clinical trial drugs or using clinical trial equipment within 3 months prior to screening ; 11. Those who have donated blood or losed a large amount of blood (=400ml) or received blood transfusion or used blood products within 3 months prior to screening; 12. Positive pregnancy test or or breastfeeding women; 13. Those who have difficulty in collecting blood intravenously or those who suffer from needle and blood sickness; 14. Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250ml) per day; 15. Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to screening or who were unable to stop using any tobacco-based products during the trial; 16. Alcoholics or regular drinkers who consume more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol by volume or 150 ml of wine) in the 6 months prior to screening or those who are unable to stop the use of any alcohol-containing products during the trial; 17. Those with a history of drug use or a positive screening for substance abuse; 18. Those who have special dietary requirements or who are unable to comply with the diet provided and the corresponding regulations, or who are unable to avoid xanthine/caffeine-containing beverages (coffee, tea, cola, etc.) or foods (animal liver, chocolate, etc.) from 48 hours prior to dosing to the end of the study,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerance outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed