Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
NCT ID: NCT03202992
Last Updated: 2019-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2017-08-11
2019-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose 1 -Single Ascending Dose (SAD)
SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
ABI-1968
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
Dose 2 -Single Ascending Dose (SAD)
SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
ABI-1968
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
Dose 3 -Single Ascending Dose(SAD)
SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
ABI-1968
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
Dose 4 -Single Ascending Dose(SAD)
SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
ABI-1968
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
Dose 5 -Single Ascending Dose(SAD)
SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
ABI-1968
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
Dose 1 - Multiple Ascending Dose(MAD)
MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
ABI-1968
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
Dose 2 -Multiple Ascending Dose(MAD)
MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
ABI-1968
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
Dose 3 -Multiple Ascending Dose(MAD)
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
ABI-1968
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
Multiple Ascending Dose (MAD) Cohort Expansion
MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
ABI-1968
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
Dose 4-Multiple Ascending Dose(MAD)
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
ABI-1968
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
Interventions
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ABI-1968
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
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Inclusion Criteria
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
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.
27 Years
ALL
No
Sponsors
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Antiva Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Operations
Role: STUDY_CHAIR
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Locations
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Research Center
San Francisco, California, United States
Research Center
Orlando, Florida, United States
Research Center
Chicago, Illinois, United States
Research Center
New York, New York, United States
Research Center
Winston-Salem, North Carolina, United States
Research Center
Sydney, Darlinghurst, Australia
Countries
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Other Identifiers
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ABI-1968-201
Identifier Type: -
Identifier Source: org_study_id
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