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.
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.
Completed
Phase 1
Drug | Synonyms | Arms |
---|---|---|
ABI-1968 | Dose 1 - Multiple Ascending Dose(MAD) |
Name | Type | Description | Interventions |
---|---|---|---|
Dose 1 -Single Ascending Dose (SAD) | Experimental | SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study |
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Dose 2 -Single Ascending Dose (SAD) | Experimental | SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study |
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Dose 3 -Single Ascending Dose(SAD) | Experimental | SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study |
|
Dose 4 -Single Ascending Dose(SAD) | Experimental | SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study |
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Dose 5 -Single Ascending Dose(SAD) | Experimental | SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study |
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Dose 1 - Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
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Dose 2 -Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
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Dose 3 -Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
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Multiple Ascending Dose (MAD) Cohort Expansion | Experimental | MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
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Dose 4-Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
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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 |
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 |
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 |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Antiva Biosciences |
February 7, 2019