plaque psoriasis
Conditions
Interventions
Group 2:HLK ointment (0.01%) or placebo, 10%BSA, single dose
Group 3:HLK ointment (0.03%) or placebo, 10%BSA, single dose
Group 1 :HLK ointment (0.01%) or placebo, 2%BSA, single dose
Group 4:HLK ointment (0.1%) or placebo, 10%BSA, single dose
Group 5:HLK ointment (0.03%) or placebo, 10%BSA, q12h for 9 doses
Group 6:HLK ointment (0.1%) or placebo, 10%BSA, q12h for 9 doses
Group 7:HLK ointment (0.01%) or placebo, q12h for 4 weeks
Group 8:HLK ointment (0.03%) or placebo, q12h for 4 weeks
Group 9:HLK ointment (0.1%) or placebo, q12h for 4 weeks
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the trial and fully understand the trial's contents, process, and possible adverse reactions. Voluntary participation and ability to complete trials as required; 2. Healthy adult volunteers aged 18 to 45 years; 3. Weight >= 50 kg for males, >= 45 kg for females. BMI 19-26 kg/m2; 4. Blood pregnancy test negative 1-3 days before medication for women of childbearing age. Female subjects, male subjects, and their female partners have no reproductive plan, no sperm donation or egg donation plan, and adopt voluntary and effective contraceptive measures, from 2 weeks before screening to 6 months after the last administration of medication. Ensure that one or more non-drug sexual contraceptive measures are used in sexual life from 2 weeks before screening to 1 month after the last administration of medication.
Exclusion criteria
Exclusion criteria: 1. Existing any of the following diseases or disease history: (1) Those who are suspected of being allergic to the study drug or any ingredient in the study drug, or who are known to have frequent and/or severe allergies to multiple drugs; (2) The investigator believes that the subject has skin damage or abnormalities that may affect the evaluation of the study drug administration site, such as tattoos, scars, excessive hair, birthmarks, injuries, uneven skin tone, sunburn, etc.; (3) The investigator believes that the subject has clinically relevant skin diseases that are contraindicated or affect the evaluation of the administration site, including psoriasis, eczema, acne, dermatitis, dysplastic mole, or other skin lesions, or a history of skin cancer ; (4) Those who are known to have active tuberculosis in the past or those whose clinical symptoms, signs, and laboratory tests suggest active tuberculosis; (5) Those who developed herpes zoster within one year before screening; (6) There is a history of major surgery 6 months before screening; (7) Suffering from severe organ and systemic diseases, infectious diseases, and other autoimmune diseases, malignant tumors (except those who have been cured) or other diseases that the investigator believes are not suitable for inclusion in this study; 2. Are taking or have had any of the following medication history: (1) Subjects who cannot stop using cytochrome P3A enzyme system (CYP3A) inducers or CYP3A inhibitors 14 days before the baseline visit and during the study period; (2) Have received any live vaccine within 1 month before screening or need to receive live vaccine during the study period (including within 30 days after the last dose of the study drug); (3) Use of prescription drugs within 14 days before baseline; (4) Use of non-prescription drugs within 7 days before baseline, including natural health products (such as herbal supplements), except irregular use of acetaminophen (up to 2g per day), ibuprofen and regular doses of vitamins; (5) Use external skin products (including sunscreens, moisturizers, cosmetics, insect repellents, creams, powders, lotions, sprays or gels) within 24 hours before administration; (6) Use topical skin drugs (such as external hormones, retinoic acid) at the research drug site within 21 days before the baseline; 3. Any one of the following abnormalities occurs in the laboratory test results during screening: (1) The white blood cell count, neutrophil count, lymphocyte count or hemoglobin in blood routine examination exceeds the normal reference value range and is clinically significant as judged by the investigator; (2) Alanine aminotransferase (ALT)> 1.5 times upper limit of normal (ULN) and/or aspartate aminotransferase (AST)> 1.5 times ULN and/or total bilirubin > 1.5 times ULN; (3) Serum creatinine and blood urea nitrogen (BUN) exceed the normal reference value range and have clinical significance as determined by the investigator; (4) Electrocardiogram QTcF>480?ms or other obvious electrocardiogram abnormalities, which are clinically significant as judged by the investigator; (5) Abnormalities in other laboratory tests have clinical significance, and the researchers judge that they are not suitable for enrollment; 4. General situation: (1) Pregnant or lactating women or female subjects who plan to become pregnant during the study; (2) Participate in blood donation within 3 months before screening and the blood donation volume is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration;Steady-state maximum plasma concentration;Time to peak plasma concentration;Steady-state time to peak plasma concentration;Area under the plasma concentration-time curve from zero time to the last measured concentration;Area under the plasma concentration-time curve from zero time to inferred infinite time;Steady-state area under the plasma concentration-time curve;Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram;Physical examination;Psoriasis Lesion Area and Severity Index, PASI; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed