MedTrace Logo

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

NCT06491446 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus Infection

Interventions

DRUG

ABI-2280

Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.

Sponsors & Collaborators

  • Antiva Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2025-10-16
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Australia
  • Kenya
  • Mexico
  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06491446 on ClinicalTrials.gov