This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of patients with moderate or severe atopic dermatitis (AD).~Patients will undergo screening evaluations to determine eligibility up to 30 days prior to randomization. Patients who meet all the entry criteria will be randomized on Day 1 to active or vehicle treatment. Patients will apply study drug (ATI-1777 topical solution 2.0% w/w or vehicle) twice daily for 4 weeks with weekly study visits and will return 2 weeks after the last dose of study medication for a Post treatment Follow-up (PTFU) Visit. Adverse event (AE) collection, physical examinations, clinical disease assessments (Eczema Area and Severity Index [EASI], Investigator's Global Assessment [IGA], AD body surface area [BSA], Peak Pruritus Numerical Rating Scale [PP-NRS]), vital sign assessments, PK evaluations, and clinical laboratory evaluations will be performed as detailed in the Schedule of Events.
This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of patients with moderate or severe atopic dermatitis.