Title
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Phase
Phase 1Lead Sponsor
Antiva BiosciencesStudy Type
InterventionalStatus
Completed No Results PostedIntervention/Treatment
ABI-1968Study Participants
57This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Inclusion Criteria: Female or male subjects, at least 27 years old. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment. Exclusion Criteria: Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer. History of genital herpes with > 3 outbreaks per year. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
