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

Primary Purpose

HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ABI-1968

About this trial

This is an interventional treatment trial for HSIL, High-Grade Squamous Intraepithelial Lesions

Eligibility Criteria

27 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Female or male subjects, at least 27 years old.
Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
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:

Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
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.
History of genital herpes with > 3 outbreaks per year.
Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Sites / Locations

Research Center
Research Center
Research Center
Research Center
Research Center
Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

Dose 1 -Single Ascending Dose (SAD)

Dose 2 -Single Ascending Dose (SAD)

Dose 3 -Single Ascending Dose(SAD)

Dose 4 -Single Ascending Dose(SAD)

Dose 5 -Single Ascending Dose(SAD)

Dose 1 - Multiple Ascending Dose(MAD)

Dose 2 -Multiple Ascending Dose(MAD)

Dose 3 -Multiple Ascending Dose(MAD)

Multiple Ascending Dose (MAD) Cohort Expansion

Dose 4-Multiple Ascending Dose(MAD)

Arm Description

SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study

SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study

SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study

SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study

SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study

MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29

MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL

Number of participants with Adverse Events related to treatment

Secondary Outcome Measures

Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.

Plasma concentrations of ABI-1968 over time

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

Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology

Full Information

NCT ID

NCT03202992

First Posted

June 24, 2017

Last Updated

February 5, 2019

Sponsor

Antiva Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT03202992

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

August 11, 2017 (Actual)

Primary Completion Date

February 4, 2019 (Actual)

Study Completion Date

February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antiva Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

The study will be conducted in 2 Phases: Part A, up to 5 cohorts of 3 subjects each will receive a single dose of ABI-1968 Topical Cream. In Part B, three cohorts (3 subjects per cohort) will receive multiple doses in 3 ascending dose strengths of ABI-1968 Topical Cream. After completing the ascending dose multiple-dosing cohorts, a multiple-dosing Cohort Expansion group of 30 subjects will be initiated.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1 -Single Ascending Dose (SAD)

Arm Type

Experimental

Arm Description

SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study

Arm Title

Dose 2 -Single Ascending Dose (SAD)

Arm Type

Experimental

Arm Description

SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study

Arm Title

Dose 3 -Single Ascending Dose(SAD)

Arm Type

Experimental

Arm Description

SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study

Arm Title

Dose 4 -Single Ascending Dose(SAD)

Arm Type

Experimental

Arm Description

SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study

Arm Title

Dose 5 -Single Ascending Dose(SAD)

Arm Type

Experimental

Arm Description

SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study

Arm Title

Dose 1 - Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Arm Title

Dose 2 -Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Arm Title

Dose 3 -Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Arm Title

Multiple Ascending Dose (MAD) Cohort Expansion

Arm Type

Experimental

Arm Description

MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Arm Title

Dose 4-Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Intervention Type

Drug

Intervention Name(s)

ABI-1968

Intervention Description

Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL

Description

Number of participants with Adverse Events related to treatment

Time Frame

SAD portion is 29 days/MAD portion is 84 days

Secondary Outcome Measure Information:

Title

Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.

Description

Plasma concentrations of ABI-1968 over time

Time Frame

SAD portion is 29 days/MAD portion is 84 days

Title

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

Description

Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology

Time Frame

SAD portion is 29 days/MAD portion is 84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

27 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female or male subjects, at least 27 years old. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. 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: Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. 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. History of genital herpes with > 3 outbreaks per year. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Operations

Organizational Affiliation

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Official's Role

Study Chair

Facility Information:

Facility Name

Research Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Research Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Research Center

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

Research Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Research Center

City

Sydney

State/Province

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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