Clinical trial · Interventional
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
NCT03239223CI-TRIAL-00039426completedPhase 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 topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervical Neoplasm | Cervical Neoplasm | ONTOLOGY_EXACT | 0.98 |
| CIN | Cervical Intraepithelial Neoplasia | CURATED_BROADER | 0.80 |
| High-grade Cervical Intraepithelial Neoplasia | High Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| High-Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
| HSIL | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
| HSIL of Cervix | High Grade Cervical Squamous Intraepithelial Neoplasia |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-1968 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose 1 - Multiple Ascending Dose (MAD)
- description
- ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
- interventionNames
- Drug: ABI-1968
- type
- EXPERIMENTAL
- label
- Dose 2 - Multiple Ascending Dose (MAD)
- description
- ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
- interventionNames
- Drug: ABI-1968
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
- timeFrame
- 85 Days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Women, 25 to 50 years old. * Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+. * Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose. * Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant). Exclusion Criteria: * Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females. * History of cancer, except basal cell or squamous cell carcinoma of the skin. * History of genital herpes with \> 3 outbreaks per year, or active non-HPV vaginal infection. * Plan to have excision or ablation of the lesion(s) within 3 months of enrollment. * History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.