Status:
RECRUITING
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
Lead Sponsor:
Antiva Biosciences
Conditions:
Human Papillomavirus Infection
Eligibility:
FEMALE
25-55 years
Phase:
PHASE1
PHASE2
Brief 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 cohor...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Female sex, 25 to 55 years of age
- Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
- Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.
- Exclusion Criteria
- History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
- Any clinically significant immune suppressing condition
- History or current diagnosis of cervical cancer, suspected or confirmed
- Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.
Exclusion
Key Trial Info
Start Date :
March 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06491446
Start Date
March 27 2024
End Date
February 28 2026
Last Update
October 29 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, South Australia, Australia
2
Emeritus Research Camberwell
Camberwell, Australia
3
Holdsworth House Medical Practice
Darlinghurst, Australia
4
KIMR
Nedlands, Australia