Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study
to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects
with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks
and then will be followed for an additional 16 weeks to determine if the study drug was
efficacious. Subjects will have routine blood draws and other safety assessments during the
study, as well as regular assessments of their toenail fungus

Inclusion Criteria:

- Subject aged 18 to 75 years.

- Diagnosis with distal subungual onychomycosis of the toenails that affects at least
one great toe (target toenail).

- Subject is willing to provide signed and dated written voluntary informed consent (and
any local or national authorization requirements) before any protocol-specific
procedures are performed.

- Subject is able to complete the study, comply with study instructions, and take study
product orally.

- Sexually active non-lactating females of childbearing potential participating in the
study must agree to use a medically acceptable method of contraception while receiving
protocol-assigned product and up to the first menses 60 days following the last dose
of study product.

- Women of childbearing potential must have a negative pregnancy test at enrollment.

- Subject has screening laboratory parameters and ECG within the normal ranges unless
considered to be not clinically relevant by the principal investigator.

Exclusion Criteria:

Subjects with any of the following conditions or characteristics will be excluded from
study enrollment (ie, will not receive study product):

- Subject has received an investigational drug within 4 weeks of the first dose of study
product, or who are scheduled to receive an investigational drug other than the study
product during the study.

- Subject has participated in a clinical trial for the systemic treatment of
onychomycosis of the toenails within 6 months prior to the first dose of study
product.

- Subject is receiving any drugs that are known substrates of the 3A4 isozyme of
cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant
medications listed under prohibited medication section.

- Subject has a history of known or suspected intolerance to albaconazole or the
formulation excipients, or to azole antifungal drugs in general.

- Subject has previously participated in a clinical study with albaconazole.

- Subject is not prepared to give up use of any nail cosmetic products for the duration
of the study.

- Subject has any known immunodeficiency or history of malignancy in the last 4 years,
excluding nonmelanoma skin cancer.

- Subject has any known liver disease or a history of liver toxicity with other drugs.

- Subject is currently suffering from any disease or condition, that could include
abnormal laboratory tests, and/or who are currently using medication which in the
opinion of the investigator may affect the evaluation of the study product or place
the subject at undue risk.

- Subject has psoriasis, lichen planus, or other abnormalities that could result in a
clinically abnormal toenail.

- Subject has a history of any condition that could possibly affect absorption of drug
(eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular
disease or peripheral circulatory impairment, or has had any major illness within 30
days prior to the screening examination.

- Subject has a history of drug, prescription medicine, or alcohol abuse within the past
2 years.

- Female subjects who are pregnant, trying to become pregnant, or lactating.

- Employees of Investigator/clinical research organization (CRO) or Stiefel
Laboratories, Inc., or an immediate family member (partner, offspring, parents,
siblings or sibling's offspring) of an employee.