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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2020-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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HSIL of Cervix HSIL, High Grade Squamous Intraepithelial Lesions High-Grade Cervical Intraepithelial Neoplasia Human Papilloma Virus HIV Negative Cervical Cancer CIN - Cervical Intraepithelial Neoplasia Cervical Neoplasm Cervical Dysplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Interventions

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Topical ABI-1968

Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No