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

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)

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

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; CIN; Human Papilloma Virus; Cervical Dysplasia; HSIL of Cervix; Cervical Neoplasm; HSIL; High-Grade Squamous Intraepithelial Lesions; High-grade Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Drug: ABI-1968

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Research Center
    • Darlinghurst, New South Wales, Australia, 2010
      • Research Center
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Research Center
• United States
  • California
    • Los Angeles, California, United States, 90036
      • Research Center
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Research Center
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Research Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Research Center
    • Winston-Salem, North Carolina, United States, 27101
      • Research Center
  • Virginia
    • Norfolk, Virginia, United States, 84304
      • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1 - Multiple Ascending Dose (MAD); ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: ABI-1968; Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Experimental: Dose 2 - Multiple Ascending Dose (MAD); ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: ABI-1968; Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL	Number of participants with Adverse Events related to treatment to determine MTD	85 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.	Plasma concentrations of ABI-1968 over time to determine systemic exposure	85 Days
Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.	Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses	85 Days

Collaborators and Investigators

• Sponsor: Antiva Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Neoplasms, Squamous Cell; Neoplasms; Uterine Cervical Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia; Papilloma
• Other Study ID Numbers: ABI-1968-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No