Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

Antiva Biosciences

Status and phase

Completed

Phase 1

Conditions

CIN

High-Grade Squamous Intraepithelial Lesions

HSIL

Human Papilloma Virus

Cervical Dysplasia

Cervical Intraepithelial Neoplasia

Cervical Neoplasm

Cervical Cancer

High-grade Cervical Intraepithelial Neoplasia

HSIL of Cervix

Treatments

Drug: ABI-1968

Study type

Interventional

Funder types

Industry

Identifiers

ABI-1968-102

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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.