A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of Topical ATB1651 in Adults With Mild to Moderate Onychomycosis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of ATB1651, a topical solution, in adults with mild to moderate onychomycosis, a fungal infection of the toenails. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess how well ATB1651 works and how safe it is when applied to the great toenail. The study plans to enroll up to 120 participants divided into multiple sequential cohorts, with an optional fourth cohort, to test different dosing regimens and strengths of the drug. Participants will be assigned to receive either ATB1651 or a placebo in a ratio of 5:1 within each cohort. Cohorts 1 to 3 will receive a 3% ATB1651 solution applied once or twice daily for 12 to 20 weeks, followed by a follow-up period lasting 16 to 24 weeks. An optional Cohort 4 may receive a 5% ATB1651 solution once daily for 12 weeks with a 24-week follow-up. Dosing in later cohorts depends on safety reviews from earlier groups. During the study, participants will visit regularly for safety assessments, blood tests to measure drug levels, and evaluations of their toenail condition. Researchers will track the complete cure rate of onychomycosis over up to 252 days and monitor for any side effects. The study will also measure various pharmacokinetic parameters such as maximum plasma concentration and elimination rates. Participant involvement includes applying the treatment daily and attending follow-up visits to assess long-term outcomes and safety.

A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis