Clinical trial · Interventional
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)
NCT03202992CI-TRIAL-00036991completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
| HIV Infection | — | UNRESOLVED | — |
| HSIL, High-Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-1968 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Dose 1 -Single Ascending Dose (SAD)
- description
- SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
- interventionNames
- Drug: ABI-1968
- type
- EXPERIMENTAL
- label
- Dose 2 -Single Ascending Dose (SAD)
- description
- SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
- interventionNames
- Drug: ABI-1968
- type
- EXPERIMENTAL
- label
- Dose 3 -Single Ascending Dose(SAD)
- description
- SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 27 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female or male subjects, at least 27 years old. 2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) 3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. 4. 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: 1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. 2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. 3. 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. 4. History of genital herpes with \> 3 outbreaks per year. 5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
References
Publications (0)
Data not yet available
No reference posted for this study.