• Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).

• Appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s), as determined by visual inspection after the nail has been trimmed. If the percentage of infection is outside this range but is still considered appropriate for this study, based on the overall impression of the Principal Investigator (PI), participation can be considered in consultation with the Medical Monitor (MM). The visual inspection results of the appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s) will be reviewed by the Sponsor before enrollment.

• The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is \< 2 mm.

• Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.

• In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination or ECG at Screening and/or before the first administration of IP at the discretion of the PI or designee. Participants with mild stable disease may be considered eligible at the discretion of the PI or designee.

• Body mass index (BMI) between 17.5 and 35.0 kg/m2, inclusive, at Screening.