Cervical Cancer, Cervical Dysplasia, Cervical Neoplasm, CIN - Cervical Intraepithelial Neoplasia, High-Grade Cervical Intraepithelial Neoplasia, HIV Negative, HSIL, High Grade Squamous Intraepithelial Lesions, HSIL of Cervix, Human Papilloma Virus
Conditions
Brief 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.
Interventions
DRUGTopical ABI-1968
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Sponsors
Antiva Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety & Tolerability of ABI-1968 for the treatment of cHSIL | 42 days | Number of Adverse Events related to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix. | 42 days | Plasma concentrations of ABI-1968 over time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Histopathology of areas with biopsy-proven disease | 42 days | Number of subjects with complete and or partial regression of cHSIL by Histopathology |
| Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream | 42 days | Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream |
Countries
South Africa
Outcome results
None listed