Actinic keratosis
Conditions
Interventions
Experimental group:HW211026 Ointment
Control group:Placebo
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) healthy adult subjects aged 18-65 years (inclusive of boundary value); (2) body weight >=50.0 kg for men and >=45.0 kg for women; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including critical value); (3) vital signs, physical examination, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function), infectious disease tests (hepatitis B virus markers, hepatitis C antibody, human immunodeficiency virus (HIV)) determined by the investigators Antibody, treponema pallidum antibody), 12-lead electrocardiogram, abdominal ultrasound and chest X-ray were normal or abnormal but of no clinical significance. (4) have no intention of becoming pregnant throughout the trial and within 3 months after the last dose and agree to use a reliable, medically accepted method of contraception during the trial and for 3 months after the last dose; (5) voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) suspected allergic or allergic to the study drug or any component in the study drug; (2) There were tattoos, birthmarks, skin scars, ulcers, sunburn, skin perforations, thin skin, abnormal fever, and other skin injuries or abnormalities in the target application area that researchers thought might affect the evaluation of the trial drug administration site; (3) patients with positive skin scratch test; (4) a history of clinically relevant skin conditions considered by the investigator to be contraindicated to the study or to affect the evaluation of the dosing site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevus, or other skin lesions, or skin cancer; (5) patients with a history of chronic or severe diseases of cardiovascular, hepatic, renal, hematological and lymphatic, endocrine, immune, psychiatric, neurological, gastrointestinal system, and the abnormalities judged by the investigators to be clinically significant; (6) vaccination with live (attenuated) vaccine within 2 months before screening; (7) patients who underwent any surgical operation within 3 months before screening or planned to undergo surgery during the study; (8) patients who had taken any medicine or health products (including Chinese herbal medicine) within 14 days before screening, and used topical medicine or tanning products in the target application area within 14 days before screening; Any drug known to induce or inhibit hepatic drug metabolism by the CYP3A4 and CYP2C19 enzymes was administered within 30 days before the screening period. CYP3A4 inducers include barbiturates, carbamazepine, phenytoin, glucocorticoids, St. John's wort, and so on. CYP3A4 inhibitors include HIV antiviral drugs, clarithromycin, ciprofloxacin, gestrinone, and so on. CYP2C19 inducers included carbamazepine, norethindrone, prednisone, and rifampicin. CYP2C19 inhibitors include proton pump inhibitors, fluoxetine, ketoconazole, etc. (10) Participants who consumed excessive amounts of tea, coffee and/or caffeine-rich beverages (> 8 cups, 1 cup =250mL) per day in the previous 3 months; (11) Heavy smokers: average daily smoking more than 5 cigarettes; Heavy drinkers: positive alcohol breath test; Or long-term, regular alcohol consumption of more than 14 units per week (1 unit =12 oz or 360 ml of beer, 5 oz or 150 ml of liquor, or 1.5 oz or 45mL of distilled spirits) in the 3 months before screening; Drug abusers: those with positive urine drug screening test; (12) pregnant or lactating women; (13) blood donation or massive blood loss =400ml within 3 months before screening; (14) those who participated in any drug clinical trial and used the trial drug within 3 months before screening; (15) those who could not tolerate venipuncture, or had a history of syncope or bleeding; (16) subjects judged by other investigators to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory inspection;Electrocardiograph;Vital signs;Physical examination;Local skin reaction;Pharmacokinetic parameters;Ldentification of metabolites; | — |
Countries
China
Contacts
Public ContactFeng Ping
West China Hospital,Sichuan University
Outcome results
None listed