Clinical Trials /

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

NCT03202992

Description:

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.

Related Conditions:
  • Anal Intraepithelial Neoplasia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
  • Official Title: Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Clinical Trial IDs

  • ORG STUDY ID: ABI-1968-201
  • NCT ID: NCT03202992

Conditions

  • HSIL, High-Grade Squamous Intraepithelial Lesions
  • Human Papilloma Virus Infection
  • HIV Infection
  • Anal Cancer
  • Anus Neoplasms

Interventions

DrugSynonymsArms
ABI-1968Dose 1 -Single Ascending Dose (SAD)

Purpose

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.

Trial Arms

NameTypeDescriptionInterventions
Dose 1 -Single Ascending Dose (SAD)ExperimentalSAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
  • ABI-1968
Dose 2 -Single Ascending Dose (SAD)ExperimentalSAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
  • ABI-1968
Dose 3 -Single Ascending Dose(SAD)ExperimentalSAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
  • ABI-1968
Dose 4 -Single Ascending Dose(SAD)ExperimentalSAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
  • ABI-1968
Dose 5 -Single Ascending Dose(SAD)ExperimentalSAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
  • ABI-1968
Dose 1 - Multiple Ascending Dose(MAD)ExperimentalMAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
  • ABI-1968
Dose 2 -Multiple Ascending Dose(MAD)ExperimentalMAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
  • ABI-1968
Dose 3 -Multiple Ascending Dose(MAD)ExperimentalMAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
  • ABI-1968
Multiple Ascending Dose (MAD) Cohort ExpansionExperimentalMAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
  • ABI-1968

Eligibility Criteria

        Inclusion Criteria:

          1. Female or male subjects, at least 27 years old.

          2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and
             confirmed by histopathology (with p16 positive staining)

          3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no
             lesion(s) is suspicious for invasive cancer.

          4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50
             copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a
             stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

        Exclusion Criteria:

          1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating
             females.

          2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to
             enrolment.

          3. History of cancer, including anal cancer (with the exception of basal cell or squamous
             cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.

          4. History of genital herpes with > 3 outbreaks per year.

          5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:27 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
Time Frame:SAD portion is 29 days/MAD portion is 84 days
Safety Issue:
Description:Number of participants with Adverse Events related to treatment

Secondary Outcome Measures

Measure:Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
Time Frame:SAD portion is 29 days/MAD portion is 84 days
Safety Issue:
Description:Plasma concentrations of ABI-1968 over time
Measure:Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.
Time Frame:SAD portion is 29 days/MAD portion is 84 days
Safety Issue:
Description:Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Antiva Biosciences

Last Updated

August 23, 2017