This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Research Center
Los Angeles, California, United States
Research Center
Lake Worth, Florida, United States
Research Center
Idaho Falls, Idaho, United States
Research Center
Chapel Hill, North Carolina, United States
Research Center
Winston-Salem, North Carolina, United States
Research Center
Norfolk, Virginia, United States
Research Center
Camperdown, New South Wales, Australia
Research Center
Darlinghurst, New South Wales, Australia
Research Center
South Brisbane, Queensland, Australia
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Number of participants with Adverse Events related to treatment to determine MTD
Time frame: 85 Days
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
Plasma concentrations of ABI-1968 over time to determine systemic exposure
Time frame: 85 Days
Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses
Time frame: 85 Days
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