Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

Inclusion criteria

• Male or female of any race and between the ages of 18 and 70 inclusive
• Clinically diagnosed onychomycosis of the target nail
• Presence of moderate to severe distal subungual onychomycosis
• A positive potassium hydroxide(KOH) microscopy test result
• A positive fungal culture for a dermatophyte
• Females of childbearing potential must be using a highly effective method of birth control and be willing to remain on the same method of birth control throughout the study
• Good general health as determined by the Investigator based on the subject's medical history and physical examination

Exclusion criteria

• Clinical significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize subject's safety
• Subjects with a history of diabetes mellitus
• Unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail solutions
• Females who are nursing, pregnant, or planning a pregnancy during the study
• Failure to complete the specified washout period(s) for the following topical medications: Antifungals drugs within 4 weeks; Anti-inflammatory drugs, corticosteroids, immunomodulators within 2 weeks
• Failure to complete the specified washout period(s) for the following systemic medications: Corticosteroids within 2 weeks; Antifungals for treatment of onychomycosis or any antifungal with known activity against dermatophyte within the previous 24 weeks or 5 half-lives of the drug, whichever is longer; Immunomodulators within 4 weeks
• History of cardiac disease and cardiac arrhythmic activity, or prolonged QT interval
• Received treatment for any type of cancer within the last 6 months
• History of any significant disease or disorder that might put subjects at risk by participating in study or influence results of study
• Nail or anatomic abnormalities of the toe
• Positive test for HIV, Hepatitis B or Hepatitis C
• History of street drug or alcohol abuse
• Donated or lost blood or participated in a clinical study which involved the withdrawal of a large volume of blood (500 mL or more), within the last 6-week
• Participated in any other trial of an investigational drug or device within 30 days or 5 half-lives of the investigational drug or participation in a research study concurrent with this study
• Unable to communicate or cooperate with the Investigator due to comprehension, mental development, or impaired cerebral function
• Presence of any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating on the study