A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

Inclusion Criteria:

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

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

3. The combined thickness of the distal nail plate at the associated hyperkeratoticnail bed is < 2 mm.

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

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

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

Exclusion Criteria:

1. History of allergy to any of the excipients in ATB1651.

2. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg),or human immunodeficiency virus (HIV) antibody at Screening or Day 1.

3. Underlying physical or psychological medical conditions that, in the opinion of thePI, would make it unlikely for the participant to comply with the protocol orcomplete the study per protocol.

4. Unwilling to refrain from the use of nail cosmetics such as clear and/ or colorednail lacquers from the Screening visit until the end of the study.

5. Use of any IP or investigational medical device within 30 days prior to Screening,or 5 half-lives of the product (whichever is the longest) or participation in morethan 4 investigational drug studies within 1 year prior to Screening.

6. Diabetes mellitus requiring treatment other than diet and exercise.