Atopic dermatitis
Conditions
Interventions
group 1:Transdermal administration of HZ-J001 (1.0%) or placebo (administration area: 3200 cm^2)
Experimental group: 10 cases, Placebo: 2 cases
group 2:Transdermal administration of HZ-J001 (1.5%) or placebo (administration area: 3200 cm^2)
Experimental group: 10 cases, Placebo: 2 cases
group 3:Transdermal administration of HZ-J001 (2.0%) or placebo (administration area: 3200 cm^2)
Experimental group: 10 cases, Placebo: 2 casesExperimental group: 10 cases, Placebo: 2 cases
group 5:Multiple transdermal administrations of HZ-J001 (2.0%) or placebo (administration area: 4800 cm2) from Day 1 to Day 9, twice daily (BID)
Experimental group: 10 cases, Placebo: 2 cases
group 4:Transdermal administration of HZ-J001 (2.0%) or placebo (administration area: 4800 cm^2)
Experimental group: 10 cases, Placebo: 2 cases
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Healthy adult subjects aged between 18 and 45 years (including boundary values); 2.Male weight >= 50.0 kg, female weight >= 45.0 kg; Body mass index (BMI) within the range of 19.0~26.0 kg/m^2 (including critical values); 3.There is no pregnancy plan during the entire clinical trial period and within 6 months after the last administration, and it is agreed to use medically accepted reliable contraceptive methods during the trial period and within 6 months after the last administration; 4.Voluntarily participate and sign the Informed Consent Form; 5.The subjects are able to communicate well with the researchers and commit to completing the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1.People who are suspected to be allergic to the study drug or any of the ingredients in the study drug, or have a history of allergic diseases (such as allergic rhinitis, allergic asthma, etc.), drug allergies, skin allergies (including but not limited to allergies to plaster, contact dermatitis to metals, cosmetics or household products), or known allergies, such as allergies to two or more drugs and food; 2.Skin scratch test positive; 3.Tattoo, birthmark, skin scar, ulceration, sunburn, skin perforation, thin skin, abnormal fever and other skin lesions or abnormalities in the target application area that researchers believe may affect the evaluation of the test drug administration site; 4.Subjects have a history of clinically relevant skin conditions deemed contraindicated in the study or affecting the evaluation of the administration site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevus, or other skin lesions, or skin cancer; 5.History of malignancy; People with a history of immune diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, etc.; Have a medical history of cardiovascular, liver, kidney, respiratory, hematological and lymphatic, endocrine, psychiatric, nervous, gastrointestinal, or skeletal disorders that the investigator believes may confuse the study results or affect drug absorption, distribution, metabolism, and excretion, or that the investigator judges to be clinically significant; 6.Patients with a history of frequent infection within one year prior to screening, or a history of recurrent oral herpes, genital herpes, shingles and other recurrent viral infections within 3 months prior to administration; Within 1 month prior to screening, infected persons identified by researchers as clinically significant had occurred, including acute and chronic infections such as abscess, boil, abscess and other local infections, respiratory tract infections, urogenital tract infections, systemic infections, etc. 7.Those who received live (attenuated) vaccine within 2 months prior to screening, or planned to receive live vaccine during the study period; 8.Had any surgical procedures in the 3 months prior to screening, or planned surgery during the study period; 9.Vital signs as determined by the investigator (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; Heart rate 100 bpm), physical examination, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function), pregnancy test (women of childbearing age), infectious disease test (human immunodeficiency virus antibody quantification, treponema syphiliae specific antibody, Hepatitis B surface antigen, hepatitis C antibody), 12-lead electrocardiogram (male QTc interval > 450ms, Female QTc interval > 470ms), abdominal B-ultrasound, chest X-ray examination results were abnormal and clinically significant; 10.Anyone who has used any drug or health product (including Chinese herbal medicine) within 14 days before the test administration, and used topical skin drugs or skin tanning products in the target application area; Study the use of topical skin products (including emollients) in the target application area within 2 days prior to drug administration; Received a biological agent (antibody or its derivatives) within 3 months prior to administration of the investigational
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs(Blood pressure, pulse, respiration);Evaluation of local skin tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics(PK parameter); | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed