Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis

Exclusion criteria

• . Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution.
• . Subjects with an abnormal ECG morphology and/or a QTcF interval \> 450 ms for males and \>470 ms for females.
• . Subjects with any history of cardiac disease or cardiac rhythm abnormalities.
• . Subjects with symptomatic tinea pedis at baseline.
• . Subjects unwilling to refrain from the use of nail cosmetics including nail lacquers from the Screening visit until the end of the study.
• . Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
• . Concomitant use of any drugs that are CYP3A and CYP2C19 substrates with QT interval prolongation potential.
• . Subjects who have not undergone the specified washout period(s) prior to Baseline visit (Day 1) for the following topical preparations, or subjects requiring the concurrent use of any of the following topical medications: Topical antifungal applied to the feet, drugs that contain luliconazole, anti-inflammatories, corticosteroids or topical immunomodulators.

Safety Assessment - Adverse Events

Timeframe: 36 days