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

Sponsor

Antiva Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT03697226

Collaborator

(none)

Enrollment

Location

Arms

17.7

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Topical ABI-1968	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions

Actual Study Start Date :

Dec 21, 2018

Actual Primary Completion Date :

May 26, 2020

Actual Study Completion Date :

Jun 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968 Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 2 Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968 Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 3 New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968 Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 4 New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968 Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 5 New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968 Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Outcome Measures

Primary Outcome Measures

Safety & Tolerability of ABI-1968 for the treatment of cHSIL [42 days]
Number of Adverse Events related to treatment

Secondary Outcome Measures

Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix. [42 days]
Plasma concentrations of ABI-1968 over time

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women, 25 to 50 years old.
Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

Exclusion Criteria:

Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
HIV positive (tested at screening visit or within 3 months of screening visit).
Resolution of visible CIN lesion prior to enrollment.
ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.