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

Summary

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.

Timeline

Start

2024-03-27

Primary completion

2025-10-16

Completion

2026-06-30

Drugs

Indications