Atopic dermatitis
Conditions
Interventions
Group 1:Single transdermal administration of 0.25% HL-300 or placebo (3 cases in the investigational drug group and 1 case in the placebo group)
Group 4:Repeated transdermal administration of 1.0% HL-300 or placebo twice daily (BID) (10 cases in the investigational drug group and 2 cases in the placebo
Group 2:Single transdermal administration of 0.5% HL-300 or placebo (6 cases in the investigational drug group and 2case in the placebo group)
Group 3:Single transdermal administration of 1.0% HL-300 or placebo (10 cases in the investigational drug group and 2case in the placebo group)
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female volunteers aged =18 years and =45 years; 2. Male weight =50 kg, female weight =45 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive), where BMI = weight (kg) / height^2 (m^2); 3. Female volunteers of childbearing potential (WOCBP) must confirm that they are not pregnant or breastfeeding, and can only enter the study after pregnancy testing (e.g., tests based on HCG ß subunit) (the date of last menstrual period must be recorded); 4. Volunteers and their partners must voluntarily use effective contraception for at least 6 months after administration of the investigational product; volunteers must not plan to donate sperm or eggs from the screening period to at least 6 months after administration; 5. Volunteers understand the informed consent form, voluntarily participate in the study, and sign the informed consent form; the signing of the informed consent form must occur prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of malignant tumor disease, or are suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and dystrophy, or any other diseases that can interfere with the test results; 2. The researchers believe that the volunteers have clinically relevant skin diseases that are taboo to study or affect the evaluation of the administration site, including psoriasis, eczema, acne, atopic dermatitis, dysplasia nevus, or other skin diseases, or a history of skin cancer; 3. Patients with a history of active tuberculosis, frequent infection within one year before screening, or recurrent viral infections such as oral herpes, genital herpes and herpes zoster within three months before administration; Infected persons with clinical significance have occurred within one month before screening, including acute and chronic infections such as abscess, furuncle, carbuncle and other local infections, respiratory tract infections, genitourinary tract infections, systemic infections, etc. 4. Suspected to be allergic to this research drug or any component in the research drug, or have allergic diseases (such as allergic rhinitis, allergic asthma, etc.), drug allergy history, skin allergy history (including but not limited to allergy to plaster, contact dermatitis to metal, cosmetics or household products), or known allergic substance, such as allergic history to two or more drugs and foods; 5. Those who have undergone surgery within 4 weeks before the trial or plan to undergo surgery during the study; 6. Those who have taken any drugs or health care products (including Chinese herbal medicines) orally within 14 days before the test and those who have used skin external drugs and skin tanning products in the target application area; Those who use skin external products (including emollients) in the target application area within 2 days before drug administration; Those who have received biological agents (antibodies or their derivatives) within 3 months before the administration of the study drug; 7. Have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the trial (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; Inhibitors-—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 8. Janus kinase (JAK) inhibitors in any dosage form have been used within one month before screening; 9. Those who participated in any clinical trials of drugs and took any clinical trial drugs within 3 months before the trial; 10. those who have been vaccinated with live (attenuated) vaccine within 2 months before screening, or plan to be vaccinated with live vaccine during the study period; 11. Those who donated blood or lost a lot of blood (>=200 mL, excluding female menstrual blood loss), received blood transfusion or used blood products within 3 months before being selected; 12. Those who have special requirements for diet and cannot follow the unified diet; 13. Those who drink too much tea, coffee and/or caffeinated drinks (8 cups or more, 1 cup =250 mL) every day, or those who have eaten a special diet (including pitaya, mango, lime, grapefruit, carambola and other fruits or corresponding juices that may affect drug metabolizing enzymes) two days before d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of local skin tolerance;Health checkup;Vital signs;Vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed