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

NCT ID: NCT03677960

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2019-06-30

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose 1 - Multiple Ascending Dose(MAD)

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Group Type: EXPERIMENTAL

Topical ABI-1968 cream

Intervention Type: DRUG

Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Dose 2 - Multiple Ascending Dose(MAD)

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Group Type: EXPERIMENTAL

Topical ABI-1968 cream

Intervention Type: DRUG

Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Dose 3 - Multiple Ascending Dose(MAD)

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Group Type: EXPERIMENTAL

Topical ABI-1968 cream

Intervention Type: DRUG

Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Interventions

Topical ABI-1968 cream

Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Intervention Type: DRUG

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 involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years

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.

• Minimum Eligible Age: 27 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antiva Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Center

Chicago, Illinois, United States

Research Center

Darlinghurst, Sydney, Australia

Countries

United States; Australia

Other Identifiers

ABI-1968-202

Identifier Type: -

Identifier Source: org_study_id