Clinical Trials /

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

NCT03239223

Description:

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

Related Conditions:
  • Cervical Intraepithelial Neoplasia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
ABI-1968Dose 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

NameTypeDescriptionInterventions
Dose 1 - Multiple Ascending Dose (MAD)ExperimentalABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
  • ABI-1968
Dose 2 - Multiple Ascending Dose (MAD)ExperimentalABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
  • ABI-1968

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:Not yet recruiting
Lead Sponsor:Antiva Biosciences

Last Updated

October 6, 2017