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

• Status: Completed
• Trial end date: 2020-06-12
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antiva Biosciences

Criteria

Inclusion Criteria:

1. Women, 25 to 50 years old.

2. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.

3. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.

4. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.

2. HIV positive (tested at screening visit or within 3 months of screening visit).

3. Resolution of visible CIN lesion prior to enrollment.

4. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.

5. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.