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ACTIVE NOT RECRUITING
NCT06491446
PHASE1/PHASE2

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

Sponsor: Antiva Biosciences

View on ClinicalTrials.gov

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

Interventions

DRUG

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