Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 6:13 PM
Study NCT ID:
NCT03202992
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2017-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2017-06-24', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL', 'timeFrame': 'SAD portion is 29 days/MAD portion is 84 days', 'description': 'Number of participants with Adverse Events related to treatment'}], 'secondaryOutcomes': [{'measure': 'Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.', 'timeFrame': 'SAD portion is 29 days/MAD portion is 84 days', '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.', 'timeFrame': 'SAD portion is 29 days/MAD portion is 84 days', 'description': 'Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HSIL, High-Grade Squamous Intraepithelial Lesions', 'Human Papilloma Virus Infection', 'HIV Infection', 'Anal Cancer', 'Anus Neoplasms']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '27 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female or male subjects, at least 27 years old.\n2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)\n3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.\n4. 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.\n\nExclusion Criteria:\n\n1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.\n2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.\n3. 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.\n4. History of genital herpes with \\> 3 outbreaks per year.\n5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.'}, 'identificationModule': {'nctId': 'NCT03202992', 'briefTitle': 'Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Antiva Biosciences'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ABI-1968-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 -Single Ascending Dose (SAD)', 'description': 'SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 -Single Ascending Dose (SAD)', 'description': 'SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 -Single Ascending Dose(SAD)', 'description': 'SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4 -Single Ascending Dose(SAD)', 'description': 'SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 5 -Single Ascending Dose(SAD)', 'description': 'SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1 - Multiple Ascending Dose(MAD)', 'description': 'MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 -Multiple Ascending Dose(MAD)', 'description': 'MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 -Multiple Ascending Dose(MAD)', 'description': 'MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Dose (MAD) Cohort Expansion', 'description': 'MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29', 'interventionNames': ['Drug: ABI-1968']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4-Multiple Ascending Dose(MAD)', 'description': 'MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29', 'interventionNames': ['Drug: ABI-1968']}], 'interventions': [{'name': 'ABI-1968', 'type': 'DRUG', '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', 'armGroupLabels': ['Dose 1 - Multiple Ascending Dose(MAD)', 'Dose 1 -Single Ascending Dose (SAD)', 'Dose 2 -Multiple Ascending Dose(MAD)', 'Dose 2 -Single Ascending Dose (SAD)', 'Dose 3 -Multiple Ascending Dose(MAD)', 'Dose 3 -Single Ascending Dose(SAD)', 'Dose 4 -Single Ascending Dose(SAD)', 'Dose 4-Multiple Ascending Dose(MAD)', 'Dose 5 -Single Ascending Dose(SAD)', 'Multiple Ascending Dose (MAD) Cohort Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '2010', 'city': 'Sydney', 'state': 'Darlinghurst', 'country': 'Australia', 'facility': 'Research Center', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Clinical Operations', 'role': 'STUDY_CHAIR', 'affiliation': 'Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may use the contacts provided below.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antiva Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}