Atopic dermatitis,AD
Conditions
Interventions
Cohort1:After a single application of 5 g of 1% TUL01101 ointment, administered over an area of 10% BSA, for 3 days, and after the investigator has assessed that the subject is tolerant and there are
Cohort2:Single and multiple dosing (2% concentration) studies of Cohort2 to Cohort4 will be conducted group by group at doses per cohort based on the results of safety and tolerability of single and m
Cohort3:Day1 to Day3Cohort3Apply 10g of concentration 2% D4-D9 to the dosing area twice daily for 7 consecutive days, dosing area 20% BSA10 subjects were enrolled in the cohort group (8 subjects were
Cohort4:Day1 to Day3Cohort4Apply10 subjects were enrolled in the cohort group (8 subjects were randomized to TUL01101 ointment and 2 subjects to placebo in a 4:1 ratio in each group) 15g concentration
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Gender: male or female 2) Age: age 18-55 years (including the threshold) 3) Weight = 50kg for men and = 45kg for women at the time of screening, with a body mass index (BMI) between 19-26kg/m2 (BMl = weight (kg)/height 2 (m2)), including the critical value of 4) No breakage, injury, sunburn, redness, rash, or abnormal fever and tattoo, birthmark, skin scar, skin perforation, etc., on the skin of the target application area at the time of screening and prior to administration, and consent to shave the skin of the area (if any); 5) Subjects (including their partners) voluntarily use appropriate contraception (see Appendix 1 for specific contraceptive measures) from 2 weeks prior to dosing to 3 months after the end of the study, and have no plans to donate sperm or eggs within 3 months of the end of the study: 6) The subject is able to communicate well with the investigator and understands and complies with the requirements of this trial: 7) Subjects voluntarily participate in the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded! 1) Persons who are allergic to this study 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 creams, contact dermatitis to metals, cosmetics or household products), or known hypersensitivity. 2) previous serious or clinically significant disease or abnormality at screening, including but not limited to cardiovascular, neurological, respiratory, hematologic and lymphatic, digestive, immune, hepatic, renal, metabolic and skeletal system diseases or psychiatric disorders 3) Cancer (other than squamous cell carcinoma, basal cell carcinoma or skin cancer in situ cured by cryosurgery or surgical excision only) within 5 years prior to screening. 4) Skin disease at the time of screening, including psoriasis, eczema, tuberculosis, atopic dermatitis, dysplastic nevus, or other skin lesions, or that may interfere with the administration and observation of the test drug. 5) A history of frequent infections (3 episodes) within one year prior to screening, or a history of recurrent viral infections such as recurrent oral rash, genital rash, or zoster within 3 months prior to drug administration, or an infection that has been judged by the investigator to be clinically significant within 1 month prior to screening, including acute and chronic infections such as abscess, treatment, carbuncle, and other local infections, respiratory tract infections genitourinary tract infections, and systemic infections. 6) Clinical symptoms, signs, laboratory tests or X-ray chest tests suggestive of active tuberculosis at the time of screening 7) Surgery within 1 month prior to screening that had an impact on the evaluation of the trial, or surgery planned within 1 month from the start to the end of the study. 8) Abnormal vital signs at screening (systolic blood pressure 90 mmHg or >140 mmHg, diastolic blood pressure 90 mmHg: heart rate 100 bpm) or abnormal electrocardiogram (OTc interval >450 ms for men, OTc interval >470 ms for women) or abnormal physical examination, chest X-ray, B-ultrasound, laboratory tests with clinical significance (as determined by the clinician). 9) Positive hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody test at screening 10) History of drug use for any reason (including topical, nutraceutical, herbal) within 2 weeks prior to dosing, or if the investigator determines that the drug used is <5 half-lives from the start of dosing in this trial; 11) Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to screening (e.g., inducers a barbiturate carbamazepine, phenytoin, glucocorticoids, omeprazole. Inhibitors I SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, flufenoxolone, antihistamines). 12) Have received any live vaccine within 1 month prior to screening or require live vaccination during the study period (including within 30 days of the last dose of study drug). 13) Drug abusers or those who have used soft drugs (e.g., marijuana) in the 3 months prior to the test or hard drugs (e.g., cocaine, phencyclidine, etc.) in the 1 year prior to the test or who have tested positive for urine drugs. 14) Blood loss or donation of more than 200 mL in the 3 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions;Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| TUL01101 Pharmacokinetics;Major metabolites M3 pharmacokinetics;Steady-state PK parameters; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed