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This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 - Multiple Ascending Dose (MAD) | Experimental | ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Dose 2 - Multiple Ascending Dose (MAD) | Experimental | ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-1968 | Drug | Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL | Number of participants with Adverse Events related to treatment to determine MTD | 85 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix. | Plasma concentrations of ABI-1968 over time to determine systemic exposure | 85 Days |
| Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Los Angeles | California | 90036 | United States | ||
| Research Center |
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Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
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Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses |
| 85 Days |
| Lake Worth |
| Florida |
| 33461 |
| United States |
| Research Center | Idaho Falls | Idaho | 83404 | United States |
| Research Center | Chapel Hill | North Carolina | 27517 | United States |
| Research Center | Winston-Salem | North Carolina | 27101 | United States |
| Research Center | Norfolk | Virginia | 84304 | United States |
| Research Center | Camperdown | New South Wales | 2050 | Australia |
| Research Center | Darlinghurst | New South Wales | 2010 | Australia |
| Research Center | South Brisbane | Queensland | 4101 | Australia |
| ID | Term |
|---|---|
| D000081483 | Squamous Intraepithelial Lesions |
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |
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