| Eligibility |
Inclusion Criteria:
1. Healthy adult subjects between 18-55 years of age (inclusive), male or female
2. The body mass index (BMI equal to body mass/square of body height) of the subjects
ranges from 19 to 26 kg/m2 (inclusive), and males of weight not less than or equal to
50 kg, females of weight not less than or equal to 45 kg.
3. Subjects have no sperm donation, egg donation plan, no pregnancy plan and voluntarily
take effective contraceptive measures from 14 days before signing the informed consent
form to 30 days after the last dose of investigational product;
4. The subjects understand and comply with the study requirements, voluntarily
participate in the study and sign the informed consent form.
Exclusion Criteria:
1. Patients who are allergic to the investigational product or its preparation
ingredients, or have previous allergic diseases, history of drug allergy, history of
skin allergy, or known to be hypersensitive;
2. Patients with clinically relevant skin diseases that are contraindicated in the study
or affect the assessment of the administration site at screening, including but not
limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, or other skin
lesions, and a history of skin cancer;
3. Skin conditions affecting the assessment of the study drug such as ulceration, injury,
sunburn, redness and swelling, rash, or abnormal fever, tattoos, birthmarks, skin
scars, skin perforations, skin infections on the skin of the target application area
at screening and before administration, or disagreeing to removing the hair on the
skin of this site;
4. Pregnant or lactating women, and those who cannot use one or more non-drug
contraceptive measures during the trial;
5. Patients who have difficulty in collecting blood or cannot tolerate venipuncture, and
have a history of fainting needle halo;
6. Those who have special requirements for diet and cannot abide by the unified diet;
7. Excessive consumption of tea, coffee or caffeinated beverages, or consumption of
grapefruit, or xanthine-rich foods or beverages within 14 days before screening, or
inability to stop consumption of xanthine-rich foods or beverages, or grapefruit or
pomelo and products containing grapefruit or pomelo ingredients within 48 hours before
dosing and during the trial;
8. Patients who smoked more than 5 cigarettes or the same amount of tobacco daily for 3
months before screening and could not stop using any tobacco products during the
trial;
9. Regular drinkers within 6 months before screening, i.e., those who drank more than 14
units of alcohol per week or could not stop using any alcohol-containing products
during the trial; or those who took any alcohol-containing products within 48 hours
before the first dose, or those who tested positive for alcohol breath before
randomization;
10. Drug abusers or those who have used soft drugs within 3 months before screening or
hard drugs within 1 year before screening or those who have positive drug abuse
screening before randomization;
11. Blood donation or massive blood loss, receiving blood transfusion or using blood
products within 3 months before screening;
12. Any surgical procedure within 30 days prior to Screening or planned during the study
and within 30 days after the end of the study;
13. Patients who have received any live vaccines within 30 days before screening or need
to receive live vaccines during the study;
14. Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days
before screening;
15. Patients who have taken any drug or health product within 14 days before screening;
16. Patients who have participated in and used any drug or medical device clinical trials
within 3 months before screening, or within 5 half-lives of other investigational
drugs before screening;
17. Patients with previous serious or clinically significant diseases or abnormalities at
screening, including but not limited to cardiovascular system, nervous system,
respiratory system, blood and lymphatic system, digestive system, immune system,
liver, kidney, metabolism and bone system diseases or psychiatric diseases or history
of malignant tumors;
18. Abnormal vital signs or clinically significant abnormalities in physical examination,
ECG and laboratory tests (subject to the judgment of the clinical study physician);
19. Patients with active tuberculosis suggested by clinical symptoms, signs, laboratory
tests or chest radiography at screening;
20. Patients whose white blood cell count, neutrophil count, lymphocyte count or
hemoglobin in blood routine examination exceed the normal reference range and have
clinical significance judged by the investigator;
21. May increase study-related risks, may interfere with interpretation of study results,
or, in the judgment of the investigator, make the investigator and/or sponsor
unsuitable for enrollment.
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