Phase I Study to Assess Safety, Tolerability and Clinical Benefits of Topically Applied GN-037 Cream in Healthy Volunteers and Patients Diagnosed With Psoriasis

MON839.151.5

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.

2022-03-28

2022-04-28

2022-09-30

Completed

Early phase I

24

Inclusion Criteria: Healthy Volunteers 1. Male and female healthy volunteers aged 18-65 years\* 2. Volunteers who were informed about participation in the study and agreed to give their written informed consent. 3. Volunteers with negative qPCR SARS-CoV-2 result in nasopharyngeal or sputum samples 4. Volunteers in good general health (without any known disease in the history and physical examination in the 14 days before participating in the study) 5. Volunteers with negative HIV, Hepatitis B and C tests 6. Volunteers with negative alcohol breath test 7. Volunteers with negative urine addictive drug screening test (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate) 8. Volunteers who agreed not to be exposed to the direct sun light during the study 9. Female volunteers of childbearing potential must have a negative pregnancy test at the screening visit and must agree to use an effective method of contraception throughout the study 10. Volunteers who can comply with all scheduled visits, laboratory tests and other study procedures \* The principal investigator will take the necessary measures to ensure that the representation Exclusion Criteria Healthy Volunteers 1. Subjects with known hypersensitivity to any component of the study drug 2. Female volunteers who are pregnant or breastfeeding or have a positive pregnancy test 3. Volunteers with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit 4. Patients with skin atrophy, pigmentation or extensive scarring that would preclude study evaluation at targeted treatment sites 5. Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites 6. Volunteers using moisturizing or skin softening ointment/lotion/cream on their intended treatment site within 3 days prior to enrollment in the study. 7. Volunteers who cannot come to the study center for follow-up visits 8. Volunteers taking part in another clinical study concurrently 9. Volunteers with positive urine addictive drug screening test and/or alcohol test Inclusion Criteria For psoriatic patients 1. Male and female patients aged 18-65 years\* 2. Patients who were informed about participation in the study and agreed to give their written informed consent. 3. Patients with negative qPCR SARS-CoV-2 result in nasopharynx or sputum samples 4. Patients diagnosed with plaque psoriasis by a dermatologist at least 6 months before inclusion in the study 5. Patients whose lesions are less than 5% of the body surface area (BSA) 6. Patients who did not receive local or systemic treatment for plaque psoriasis, or who received the last psoriasis treatment 28 days or more before 7. Patients who are confirmed to be healthy by medical history and physical examination and who do not have any clinically significant disease/condition other than plaque psoriasis that could affect the study evaluation. 8. Patients with disease severity with Physician's Global Assessment (IGA) score ≥3 (moderate) as an overall assessment of all lesions to be treated 9. Patients with negative HIV, Hepatitis B and C tests 10. Patients with negative alcohol breath test 11. Patients with negative urine addictive drug screening test (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate) 12. Patients who agreed not to be exposed to the sun during the study 13. Female patients of childbearing potential must have a negative pregnancy test at the screening visit and must agree to use an effective method of contraception throughout the study 14. Patients who can comply with all scheduled visits, laboratory tests, and other study procedures \* The principal investigator will take the necessary measures to ensure that the representation of females and males is equal. Exclusion criteria For psoriatic patients 1. Patients with known hypersensitivity to any component of the study drug 2. Pregnant or lactating or female patients with a positive pregnancy test 3. Patients who require any other medication (topical or systemic) that may affect the course of the disease during the study period (eg antibiotics, antihistamines) 4. Patients with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit 5. Patients with skin atrophy, pigmentation, or extensive scarring that would preclude evaluation of study drug efficacy at targeted treatment sites 6. Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites 7. Patients diagnosed with pustular, guttate, inverse, exfoliative or erythrodermic psoriasis at targeted treatment sites 8. Patients with a history of psoriasis unresponsive to topical treatments 9. Patients who used moisturizer or skin softening ointment/lotion/cream to the intended treatment areas within 3 days prior to enrolling in the study. 10. Patients who cannot come to the study center for follow-up visits 11. Patients taking part in another clinical study concurrently 12. Patients with positive urine addictive drug screening test and/or alcohol test

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double blind, placebo controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Identical tubes with no indicative label, identical creams with similiar texture and odor', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-06-13