Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Phase 1
Completed
- Conditions
- HSIL, High-Grade Squamous Intraepithelial LesionsHuman Papilloma Virus InfectionHIV InfectionAnal CancerAnus Neoplasms
- Interventions
- Registration Number
- NCT03202992
- Lead Sponsor
- Antiva Biosciences
- Brief Summary
This 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose 1 -Single Ascending Dose (SAD) ABI-1968 SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study Dose 5 -Single Ascending Dose(SAD) ABI-1968 SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study Dose 4 -Single Ascending Dose(SAD) ABI-1968 SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study Dose 4-Multiple Ascending Dose(MAD) ABI-1968 MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Dose 2 -Single Ascending Dose (SAD) ABI-1968 SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study Dose 3 -Single Ascending Dose(SAD) ABI-1968 SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study Dose 1 - Multiple Ascending Dose(MAD) ABI-1968 MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Dose 2 -Multiple Ascending Dose(MAD) ABI-1968 MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Dose 3 -Multiple Ascending Dose(MAD) ABI-1968 MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Multiple Ascending Dose (MAD) Cohort Expansion ABI-1968 MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL SAD portion is 29 days/MAD portion is 84 days Number of participants with Adverse Events related to treatment
- Secondary Outcome Measures
Name Time Method Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream. SAD portion is 29 days/MAD portion is 84 days Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal. SAD portion is 29 days/MAD portion is 84 days Plasma concentrations of ABI-1968 over time
Trial Locations
- Locations (1)
Research Center
🇦🇺Sydney, Darlinghurst, Australia