Clinical Research Directory

Inclusion Criteria: * Adult men and women age ≥ 18 years * Capable of informed consent * Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA. * Positive anal human papillomavirus (HPV) test. * Women of childbearing potential agree to use birth control for the duration of the study. * Laboratory values at Screening of: 1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN) 2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN 3. Serum Bilirubin (total) \< 2.5 x ULN 4. Serum Creatinine ≤ 1.5 x ULN * Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator. * Weight ≥ 50kg Exclusion Criteria: * Pregnant and nursing women * Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA * Concurrent anal, vulvar, cervical, or penile cancer * HIV-seropositivity * Currently receiving systemic chemotherapy or radiation therapy for another cancer. * Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study. * Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors * Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study