Atopic dermatitis
Conditions
Interventions
Queue 1:Eight volunteers were given a dose of 13.5 mg/d and two volunteers were given the same quality of placebo
Queue 2:Eight volunteers were given a dose of 54 mg/d and two volunteers were given the same quality of placebo
Queue 3:Eight volunteers were given a dose of 135 mg/d and two volunteers were given the same quality of placebo
Queue 4:Eight volunteers were given a dose of 180 mg/d and two volunteers were given the same quality of placebo
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Each subject participating in the study must also meet all of the following enrollment criteria: 1) Healthy subjects aged 18 ~ 55 years (including the threshold), both men and women; 2) Male subjects weighing = 50.0 kg and female subjects weighing = 45.0 kg with a body mass index (BMI) between 19 ~ 26 kg/m2 (including the threshold); 3) Subjects (including partners) have no plans for sperm donation or egg donation, no plans for pregnancy and voluntarily use effective contraception from 14 days prior to signing the informed consent until 30 days after the last dose of the drug used in the trial; 4) Understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: Any one of the following criteria is met and is excluded: 1) Persons who are allergic to the test drug or its formulation components, or who have previous allergic disease (e.g., allergic rhinitis, allergic asthma), history of drug allergy, history of skin allergy (including, but not limited to, allergy to patches or creams, contact dermatitis to metals, cosmetics, or household products), or known to be hypersensitive; 2) Persons with clinically relevant skin conditions that are contraindicated at the time of screening or that affect the assessment of the site of administration, including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic nevus, or other skin lesions, or a history of skin cancer; 3) Those with a history of frequent infections within 1 year prior to screening, or those with a history of recurrent viral infections such as recurrent oral herpes, genital herpes, or herpes zoster within 3 months prior to dosing, or those who have had an infection judged by the investigator to be clinically significant within 30 days prior to screening, including acute and chronic infections such as abscesses, boils, carbuncles, and other local infections, respiratory tract infections, genitourinary tract infections, and systemic infections; 4) Skin conditions that affect the evaluation of the study drug, such as breakage, injury, sunburn, redness, rash, or abnormal fever, tattoo, birthmark, skin scar, skin perforation, skin infection, etc., exist in the skin of the target application area at the time of screening and prior to administration, or who do not agree to the removal of hair from the skin at that site (if needed); 5) Use of topical skin medications at the study drug site within 21 days prior to randomization and skin tanning products within 14 days prior to randomization; 6) Pregnant or lactating women, and those unable to use one or more non-pharmaceutical contraceptive measures during the trial; 7) those who have difficulty collecting blood or cannot tolerate venipuncture, and those with a history of needle sickness and blood sickness; 8)Those who have special dietary requirements and cannot comply with a uniform diet; 9)Those who have consumed excessive tea, coffee or caffeine-containing beverages, or grapefruit, or xanthine-rich foods or beverages within 14 days prior to screening, or those who cannot stop consuming xanthine-rich foods or beverages, or grapefruit or pomelo and products containing grapefruit or pomelo ingredients within 48 hours prior to dosing and during the trial 10) Persons who smoked more than 5 cigarettes per day or the equivalent amount of tobacco for 3 months prior to screening and who were unable to discontinue the use of any tobacco-based products during the trial; 11) Regular drinkers within 6 months prior to screening, i.e., those who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine) or those who cannot stop using any alcohol-containing product during the trial; or those who have taken any alcohol-containing product within 48 hours prior to the first dose, or who have tested positive on a pre-randomization alcohol breath test; 12) Substance abusers or those who have used soft drugs (e.g., marijuana) in the 3 months prior to screening or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to screening or positive pre-randomization substance abuse screening; 13) Persons who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Serious Adverse Events;Physical Examination;Vital signs;12-lead electrocardiogram;Clinical Laboratory Tests;Local tolerability assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;CL/F;Vz/F;t1/2;Cmax;Tmax; | — |
Countries
China
Contacts
Public ContactYang Guoping
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed