Acne vulgaris
Conditions
Interventions
Experimental group:KR230109 Group
placebo group:placebo
Sponsors
Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Male and female subjects aged 18 years = 50 kg, female weight > = 45 kg; Body mass index (BMI) between 19~26 kg/m² (including the cut-off value); Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the whole trial process according to the requirements of the trial; From the time of signing the informed consent form to 3 months after the last dose, male/female subjects of childbearing potential agree to stop the sperm/egg donation program and are able to use effective contraceptive measures, such as avoiding sexual life or using reliable contraceptive measures such as condoms and intrauterine devices.
Exclusion criteria
Exclusion criteria: Those who are suspected of allergic to this 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 allergy to plasters, contact dermatitis to metals, cosmetics or household products), or known allergies, such as a history of allergies to two or more drugs and food; Those who have the following diseases in the past or present and are considered by the investigator to be ineligible for enrollment, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and bone and other system diseases and malignant tumors; In the opinion of the investigator, the subject has clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of the dosing site, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, atopic dermatitis, eczema and extremely severe acne, etc.; Tattoos, birthmarks, skin scars, ulcers, sunburns, skin perforations, thin skin, abnormal fever, and other skin lesions or abnormalities that the investigator believes may affect the evaluation of the test drug administration site in the target application area; Those with positive skin scratch test; Those who have a history of frequent infections within one year before screening, or a history of recurrent oral herpes, genital herpes, shingles and other recurrent viral infections within 3 months before administration; Those who have had clinically significant infections within 1 month prior to screening, including acute and chronic infections such as abscesses, boils, carbuncles and other local infections, respiratory tract infections, genitourinary tract infections, systemic infections, etc.; Those who have received live (attenuated) vaccines within 2 months before screening, or plan to receive live vaccines during the study period; Those who have undergone any surgical operation within 3 months prior to screening, or who plan surgery during the study; Those who were judged by the investigator to have abnormal vital signs, physical examination, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram (QTcF interval >450ms, QTcF calculated by Fridericia formula, QTcF=QT/(RR^0.33)), abdominal B-ultrasound, and anteroposterior chest X-ray examination results were abnormal and clinically significant; Those who have used any drugs or health products (including Chinese herbal medicines) within 14 days before the trial administration, as well as those who have used topical skin drugs and skin tanning products in the target application area; Those who use topical skin products (including emollients) in the target application area within 2 days before the administration of the study drug; Those who have received biological agents (antibodies or their derivatives) within 3 months before the administration of the study drug; Use of any CYP3A4 inhibitors/inducers within 1 month before screening (strong inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone, etc., moderate inhibitors such as erythromycin, verapamil, etc., weak inhibitors such as vorfoxamine, etc.; strong inducers such as carbamazepine, phenytoin, phenobarbital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharamcokinetics,PK; | — |
Countries
China
Contacts
Public ContactYang Guoping
Third Xiangya Hospital of Central South University
Outcome results
None listed