Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
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)
1 other identifier
interventional
57
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2017
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedStudy Start
First participant enrolled
August 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2019
CompletedFebruary 7, 2019
February 1, 2019
1.5 years
June 24, 2017
February 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
Number of participants with Adverse Events related to treatment
SAD portion is 29 days/MAD portion is 84 days
Secondary Outcomes (2)
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
SAD portion is 29 days/MAD portion is 84 days
Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.
SAD portion is 29 days/MAD portion is 84 days
Study Arms (10)
Dose 1 -Single Ascending Dose (SAD)
EXPERIMENTALSAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
Dose 2 -Single Ascending Dose (SAD)
EXPERIMENTALSAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
Dose 3 -Single Ascending Dose(SAD)
EXPERIMENTALSAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
Dose 4 -Single Ascending Dose(SAD)
EXPERIMENTALSAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
Dose 5 -Single Ascending Dose(SAD)
EXPERIMENTALSAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
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
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
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
Multiple Ascending Dose (MAD) Cohort Expansion
EXPERIMENTALMAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Dose 4-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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Research Center
San Francisco, California, 94115, United States
Research Center
Orlando, Florida, 32803, United States
Research Center
Chicago, Illinois, 60614, United States
Research Center
New York, New York, 10011, United States
Research Center
Winston-Salem, North Carolina, 27157, United States
Research Center
Sydney, Darlinghurst, 2010, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Operations
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Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2017
First Posted
June 29, 2017
Study Start
August 11, 2017
Primary Completion
February 4, 2019
Study Completion
February 4, 2019
Last Updated
February 7, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share