Description:
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical
precancerous lesions in adult women.
Title
- Brief Title: Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
- Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
Clinical Trial IDs
- ORG STUDY ID:
ABI-1968-102
- NCT ID:
NCT03239223
Conditions
- HSIL
- HSIL of Cervix
- High-Grade Squamous Intraepithelial Lesions
- High-grade Cervical Intraepithelial Neoplasia
- Human Papilloma Virus
- Cervical Cancer
- Cervical Intraepithelial Neoplasia
- Cervical Neoplasm
- Cervical Dysplasia
- CIN
Interventions
Drug | Synonyms | Arms |
---|
ABI-1968 | | Dose 1 - Multiple Ascending Dose (MAD) |
Purpose
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical
precancerous lesions in adult women.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose 1 - Multiple Ascending Dose (MAD) | Experimental | ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 | |
Dose 2 - Multiple Ascending Dose (MAD) | Experimental | ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 | |
Eligibility Criteria
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.
Maximum Eligible Age: | 50 Years |
Minimum Eligible Age: | 25 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL |
Time Frame: | 85 Days |
Safety Issue: | |
Description: | Number of participants with Adverse Events related to treatment to determine MTD |
Secondary Outcome Measures
Measure: | Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix. |
Time Frame: | 85 Days |
Safety Issue: | |
Description: | Plasma concentrations of ABI-1968 over time to determine systemic exposure |
Measure: | Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream. |
Time Frame: | 85 Days |
Safety Issue: | |
Description: | Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Antiva Biosciences |
Last Updated
July 10, 2019