Clinical trial NCT03239223: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Antiva Biosciences
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.


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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
timeFrame: 85 Days
Secondary outcomes:
measure: Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
timeFrame: 85 Days
measure: Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
timeFrame: 85 Days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Lake Worth
country: United States
facility: Research Center
state: Florida
city: Idaho Falls
country: United States
facility: Research Center
state: Idaho
city: Chapel Hill
country: United States
facility: Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Center
state: North Carolina
city: Norfolk
country: United States
facility: Research Center
state: Virginia
city: Camperdown
country: Australia
facility: Research Center
state: New South Wales
city: Darlinghurst
country: Australia
facility: Research Center
state: New South Wales
city: South Brisbane
country: Australia
facility: Research Center
state: Queensland
Study officials:
References: