Cervical Cancer, Cervical Dysplasia, Cervical Intraepithelial Neoplasia, Cervical Neoplasm, CIN, High-grade Cervical Intraepithelial Neoplasia, High-Grade Squamous Intraepithelial Lesions, HSIL, HSIL of Cervix, Human Papilloma Virus
Conditions
Brief summary
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Interventions
DRUGABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Sponsors
Antiva Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL | 85 Days | Number of participants with Adverse Events related to treatment to determine MTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix. | 85 Days | Plasma concentrations of ABI-1968 over time to determine systemic exposure |
| Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream. | 85 Days | Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses |
Countries
Australia, United States
Outcome results
None listed