Psoriasis
Conditions
Interventions
MAD group (multiple-dose dose escalation study) B1 group:Randomly apply 160mg of INNA1605 ointment or placebo to the skin of the subjects in a ratio of 6:2.
Group A1 of SAD (Single Dose Escalation Study):Randomly apply 60mg of INNA1605 ointment or placebo to the skin of the subjects in a ratio of 6:2.
MAD group (multiple-dose dose escalation study) B2 group:Randomly apply 320mg of INNA1605 ointment or placebo to the skin of the subjects in a ratio of 6:2.
SAD Group (Single dose escalation study) Group A2:Randomly apply 180mg of INNA1605 ointment or placebo to the skin of the subjects in a ratio of 6:2.
SAD Group (Single dose escalation study) Group A3:Randomly apply 270mg of INNA1605 ointment or placebo to the skin of the subjects in a ratio of 6:2.
SAD Group (Single dose escalation study) Group A4:Randomly apply 270mg of INNA1605 ointment or placebo to the skin of the subjects in a ratio of 6:2.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participants must sign the informed consent form, fully understand the study content, procedures and possible adverse reactions, and record the date of signature. 2. Healthy Chinese male or female participants aged 18 to 55 years inclusive. 3. Male participants must have a body weight of at least 50 kg, and female participants must have a body weight of at least 45 kg. Body mass index must be within 19.0 to 26.0 kg/m^2 inclusive. 4. Participants must be generally healthy, as assessed by the investigator based on medical history, surgical history, complete physical examination, vital signs, 12-lead ECG and laboratory test results, with no evidence suggesting active or chronic disease. 5. Participants and their partners must have no pregnancy plan, including sperm donation or egg donation, from 2 weeks before screening to 3 months after the last dose, and must voluntarily use effective contraceptive measures. Non-pharmacological contraception must be used during the study. 6. Participants must be willing to understand and comply with the study procedures and restrictions, be able to complete the study as scheduled, and be able to communicate effectively with the investigators.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of hypersensitivity or allergic reaction to any component of the investigational drug, or to other drugs or foods. 2. Participants with a current or previous history of thyroid disease. 3. Participants with a history of clinically significant disease, including hepatic, renal, endocrine, gastrointestinal, metabolic, hematologic, pulmonary, neurologic, psychiatric or allergic disease, including drug allergy, but excluding untreated and asymptomatic seasonal allergy at the time of dosing. 4. Participants with tattoos in the skin area where the ointment needs to be applied. 5. Participants who are unwilling to remove hair from the application area by any method, including plucking, waxing or depilatory cream, during the study, if there is coarse hair on the skin of the dosing site. 6. Participants with any skin disease or infection that may interfere with study assessment in the skin area where the ointment needs to be applied, such as acne, impetigo, or other skin comorbidities. 7. Participants with a history of sensitivity to non-steroidal anti-inflammatory drugs. 8. Participants who have received cryolipolysis, chemical resurfacing, dermabrasion, laser treatment, nevus removal surgery, or X-ray treatment within 1 month before screening. 9. Participants who have used tanning beds, sun lamps, sunbathing, including excessive exposure to sunlight, or tanning products within 1 month before screening or during the study. 10. Participants who have undergone major surgery within 6 months before screening, or who plan to undergo surgery during the study. 11. Participants with clinically significant heart disease, or abnormal 12-lead ECG results during screening or at baseline that are judged clinically significant by the investigator, including but not limited to first-degree atrioventricular block greater than 1 degree, resting heart rate greater than 100 bpm or less than 50 bpm, or QTcF greater than 450 ms. 12. Participants with positive infectious disease screening results during screening, including human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody, or Treponema pallidum antibody. 13. Participants with any of the following laboratory abnormalities during screening, if judged clinically significant by the investigator after laboratory assessment and repeated confirmation when considered necessary: white blood cell count, neutrophil count, lymphocyte count, hemoglobin, eosinophil count or basophil count outside the reference range; aspartate aminotransferase, alanine aminotransferase or total bilirubin greater than 1.5 times the upper limit of normal; serum creatinine, serum urea or blood urea nitrogen outside the reference range; or any other clinically significant laboratory abnormality. 14. Female participants with a positive blood pregnancy test at screening or on Day -1. 15. Participants who have used any prescription drug, non-prescription drug, vitamin product or Chinese herbal medicine within 2 weeks or 5 half-lives before screening, whichever is longer, except for hormonal contraceptives. 16. Participants who have used topical medications within 2 weeks before screening, such as miconazole, tretinoin, anti-inflammatory drugs, antibiotics or biological agents. 17. Participants who have systemically used retinoids, antifungal drugs, anti-inflammatory drugs, systemic therapeutic corticosteroids, within 30 days before screening, or have used class
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcomes;Local skin tolerability outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic outcomes in the MAD study;Pharmacokinetic outcomes in the SAD study; | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed