Trial Title:
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
NCT ID:
NCT06491446
Condition:
Human Papillomavirus Infection
Conditions: Official terms:
Papillomavirus Infections
Conditions: Keywords:
HPV
sexually-transmitted infection
high-risk HPV
CIN
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Double-blind masking
Intervention:
Intervention type:
Drug
Intervention name:
ABI-2280
Description:
Different strength of ABI 2280 will be administered in different cohorts.
Other: Placebo Matching placebo will be administered.
Arm group label:
Experimental: Cohort 1
Arm group label:
Experimental: Cohort 10
Arm group label:
Experimental: Cohort 11
Arm group label:
Experimental: Cohort 2
Arm group label:
Experimental: Cohort 3
Arm group label:
Experimental: Cohort 4
Arm group label:
Experimental: Cohort 5
Arm group label:
Experimental: Cohort 6
Arm group label:
Experimental: Cohort 7
Arm group label:
Experimental: Cohort 8
Arm group label:
Experimental: Cohort 9
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.
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 following the use of ABI-2280 Vaginal Insert delivered
intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may
trigger cohort expansions if some evidence of efficacy is observed.
Dose range and dosing regimens in this study will be evaluated through the enrollment of
up to 11 sentinel cohorts, each enrolling up to 8 participants.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Minimum age:
25 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
PARC Clinical Research, Royal Adelaide Hospital
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Zayin Oppyus-Digaum
Email:
Zayin.oppus-digaum@sa.gov.au
Investigator:
Last name:
Mary Louise Hull
Email:
Principal Investigator
Facility:
Name:
Emeritus Research Camberwell
Address:
City:
Camberwell
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Anika-Raam Kaur
Email:
anikaraamkaur@emeritusresearch.com
Investigator:
Last name:
Louise Murdoch
Email:
Principal Investigator
Facility:
Name:
Holdsworth House Medical Practice
Address:
City:
Darlinghurst
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sanne Fennema
Email:
Sanne.fennema@holdsworthhouse.com.au
Investigator:
Last name:
Jacqueline Engelander
Email:
Principal Investigator
Facility:
Name:
KIMR
Address:
City:
Nedlands
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Madeleine Stuckey
Email:
madeleine.research@outlook.com
Investigator:
Last name:
Brownwyn Stuckey
Email:
Principal Investigator
Facility:
Name:
The Royal Women's Hospital
Address:
City:
Parkville
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Patricia Wojtowicz
Email:
Patricia.Wojtowicz@thewomens.org.au
Investigator:
Last name:
David Wrede
Email:
Principal Investigator
Facility:
Name:
Emeritus Research Sydney
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Vera Klemm
Email:
veraklemm@emeritusresearch.com
Investigator:
Last name:
Karen Kaluhin
Email:
Principal Investigator
Facility:
Name:
AusTrials Taringa
Address:
City:
Taringa
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Mariel Bahan
Email:
Mariel.bahan@austrials.com.au
Investigator:
Last name:
Florence Tiong
Email:
Principal Investigator
Facility:
Name:
AusTrials Wellers Hill
Address:
City:
Tarragindi
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jobina Lopez
Email:
Jobina.lopez@austrials.com.au
Investigator:
Last name:
Ferdinandus de Looze
Email:
Principal Investigator
Facility:
Name:
Waitemata Clinical Research Ltd
Address:
City:
Birkenhead
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Niklas Gemmell
Email:
niklas@wcresearch.co.nz
Investigator:
Last name:
Susan Smith
Email:
Principal Investigator
Facility:
Name:
P3 Research Dunedin
Address:
City:
Dunedin
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Michelle Berland
Email:
Michelle.Berland@p3research.co.nz
Investigator:
Last name:
Sarah Hortop
Email:
Principal Investigator
Facility:
Name:
P3 Research Hawke's Bay
Address:
City:
Hastings
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Crawford Davidson
Email:
crawfordd@p3research.co.nz
Investigator:
Last name:
Nine Smuts
Email:
Principal Investigator
Facility:
Name:
P3 Research Lower Hutt
Address:
City:
Lower Hutt
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Gabriela de Urtiaga
Email:
GabrielaD@p3research.co.nz
Investigator:
Last name:
Sarah (Polly) Bradford
Email:
Principal Investigator
Facility:
Name:
Pacific Clinical Trials Network - Tasman
Address:
City:
Nelson
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Esme Justo
Email:
esmejusto@pcrn.co.nz
Investigator:
Last name:
Claire Thurlow
Email:
Principal Investigator
Facility:
Name:
P3 Research Kapiti
Address:
City:
Paraparaumu
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Sonja Dreyer
Email:
SonjaD@p3research.co.nz
Investigator:
Last name:
Kim Entwisle
Email:
Principal Investigator
Facility:
Name:
Lakeland Clinical Trials
Address:
City:
Rotorua
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Deidre Monga
Email:
deidremonga@pcrn.co.nz
Investigator:
Last name:
Dean Tasker
Email:
Principal Investigator
Facility:
Name:
Clinical Horizons New Zealand
Address:
City:
Tauranga
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Tracy Paterson
Email:
tracy@clinicalhorizons.co.nz
Investigator:
Last name:
Andrew Corin
Email:
Principal Investigator
Start date:
March 27, 2024
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Antiva Biosciences
Agency class:
Industry
Source:
Antiva Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06491446
