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)

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

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.