This is an open-label study to evaluate the safety, tolerability, and efficacy of ABI-2280 in participants with cervical squamous intraepithelial lesions. This study is divided into 2 parts - Part A and Part B. Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts. Participants will self-administer ABI-2280.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Vaginal Tablet
East Sydney Doctors
Darlinghurst, New South Wales, Australia
RECRUITINGCerviCusco
Cusco, Peru
RECRUITINGGinobs S.A.
Lima, Peru
Incidence of Adverse Events (Safety and Tolerability)
For Parts A and B, to assess the safety and tolerability of ABI-2280 Vaginal Tablet by the incidence and severity of Adverse events (AEs).
Time frame: From Baseline to Day 42 post dose administration
Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) speciment
To assess histopathologic changes in cHSIL by LLETZ
Time frame: 12 weeks after the first dose of ABI-2280 Vaginal Tablet
Pharmacokinetics of ABI-2280 after single and multiple doses
Pharmacokinetics sampling of ABI-2280 will be taken at various time points after single and multiple doses to assess systemic exposure.
Time frame: PK time points will begin on Day 1 and will continue up to Day 49 (depending on the Cohort)
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Farmovs
Bloemfontein, Free State, South Africa
RECRUITINGNafasi Integrated Solutions
Sunnyside, Gauteng, South Africa
RECRUITINGBotho ke Bontle Health Services
Waltloo, Gauteng, South Africa
RECRUITINGGole Biomedical Research Centre
Ga-Mothapo, Limpopo, South Africa
RECRUITING