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Completed

NCT Number: NCT03239223

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

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

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Key information

Conditions

HSIL CIN Cervical Cancer Cervical Dysplasia Cervical Intraepithelial Neoplasia Cervical Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HSIL of Cervix High-Grade Squamous Intraepithelial Lesions High-grade Cervical Intraepithelial Neoplasia Human Papilloma Virus Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Precancerous Conditions Squamous Intraepithelial Lesions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Center, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABI-1968

Drug

Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL

    Time frame: 85 Days

    Number of participants with Adverse Events related to treatment to determine MTD

Secondary outcomes

  1. Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.

    Time frame: 85 Days

    Plasma concentrations of ABI-1968 over time to determine systemic exposure

  2. Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Antiva Biosciences

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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