In this single-center, randomized, double-blind, placebo-controlled, and two-stage Phase I study, it was planned to evaluate the safety, tolerability and clinical efficacy of topically applied GN-037 cream in healthy volunteers and patients diagnosed with plaque psoriasis.
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.
The study will be performed in two stages; healthy volunteers and patients. After consenting procedures, all subjects will be evaluated for their eligibility for the study. An electronic case report form (e-CRF) specially designed for this study will be used to record the data of the screened volunteers. This e-CRF will assign a volunteer number to each volunteer, as well as providing randomization.
During the screening visit (day 0), a swab for the real-time RT-PCR COVID-19 test will be obtained from all subjects before hospitalization who met the study criteria and gave informed voluntary consent, following the physical examination and screening tests, the volunteers will be interned at the clinic for overnight observation. Hospitalization will be carried out for app 24 hours.
In the healthy subject section of the study, GN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo will be applied to 18 healthy volunteers and will be tested as low dose, medium dose and high dose according to the surface area to be applied in the selected target area. A placebo will be administered to a total of 6 healthy volunteers. All applications will be performed by the investigators during the initial application period and subjects will continue applications as instructed.
GN-037 cream and placebo application will be divided into different stages according to the dose groups specified below, and all volunteers will not be applied on the same day. The study will first start with the administration of low dose GN-037 cream and placebo and will continue through increasing the dosage, hence the applied surface area
* Low dose: 6 healthy volunteers in an area of 5 cm2 in the knee and/or elbow area.
* Medium dose: 6 healthy volunteers on an area of 15 cm2 in the knee and/or elbow area.
* High dose: 6 healthy volunteers will be applied a thin film of GN-037 cream or placebo to an area of 30 cm2 in the knee and/or elbow region, twice a day, morning and evening, for 14 days.
Placebo product will resemble the active products in weight, color and texture.
6 healthy volunteers who were admitted to the clinic at the screening visit will be randomized 2:1 to the low-dose GN-037 cream (n=4) or low-dose placebo (n=2) arm on day 1 of the study. Volunteers in the low dose group will be evaluated for safety data on day 10. If these safety results are found to be appropriate, 6 more healthy volunteers will be recruited for medium dose administration and will be randomized in a 2:1 ratio, with 4 volunteers assigned to the GN-037 cream arm and 2 volunteers to the placebo arm. After safety assessment high dose administration will be initiated. High dose group, will be randomized at a ratio of 2:1; as active:placebo and after final safety evaluation patients with plaque psoriasis (n=6) will be included in the study. All inclusion and efficacy/safety evaluations will be performed by a dermatologist.
All subjects will be treated for 14 days (active and placebo) and a final safety evaluation will be performed on day 19. Study drugs will be collected on this visit and the cream usage will be measured by weighing the used cream tubes. On day 28, a telephone visit will be performed for final safety evaluation.
