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Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
Sponsor: Antiva Biosciences
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.
Official title: A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
Key Details
Gender
FEMALE
Age Range
25 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2024-03-27
Completion Date
2026-06-30
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
ABI-2280
Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Locations (24)
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Emeritus Research Camberwell
Camberwell, Australia
Holdsworth House Medical Practice
Darlinghurst, Australia
KIMR
Nedlands, Australia
The Royal Women's Hospital
Parkville, Australia
Emeritus Research Sydney
Sydney, Australia
AusTrials Taringa
Taringa, Australia
AusTrials Wellers Hill
Tarragindi, Australia
International Cancer Institute
Eldoret, Kenya
Victoria Cancer Care & Research Centres
Kisii, Kenya
Kenya Medical Research Institute (KEMRI) - RCTP Kisumu
Kisumu, Kenya
Victoria Biomedical Research Institute
Kisumu, Kenya
Arke Estudios Clinicos S.A. De C.V.
Cuauhtémoc, Mexico
Centro Oncologico Internacional
Mexico City, Mexico
Unidad de Medicina Especializada SMA
Querétaro, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Mexico
Waitemata Clinical Research Ltd
Birkenhead, New Zealand
P3 Research Dunedin
Dunedin, New Zealand
P3 Research Hawke's Bay
Hastings, New Zealand
P3 Research Lower Hutt
Lower Hutt, New Zealand
Pacific Clinical Trials Network - Tasman
Nelson, New Zealand
P3 Research Kapiti
Paraparaumu, New Zealand
Lakeland Clinical Trials
Rotorua, New Zealand
Clinical Horizons New Zealand
Tauranga, New Zealand