Artesunate OintmentArtesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

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