Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2026-06-30

Brief Summary

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This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

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Detailed Description

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This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.

Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.

Conditions

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Human Papillomavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind masking

Study Groups

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Experimental: Cohort 1

Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo

Group Type ACTIVE_COMPARATOR