Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT06491446
Intervention or treatment
DRUG: ABI-2280
Conditions
- Human Papillomavirus Infection
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
PARC Clinical Research, Royal Adelaide Hospital
Select from list below to view details:
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Emeritus Research Camberwell
Camberwell, Australia
Holdsworth House Medical Practice
Darlinghurst, Australia
KIMR
Nedlands, Australia
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Who is running the clinical trial?
Antiva Biosciences
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Experimental: Cohort 1
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 2
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 3
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 4
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 5
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 6
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 7
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 8
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 9
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 10
| Drug: ABI-2280 |
ACTIVE_COMPARATOR: Experimental: Cohort 11
| Drug: ABI-2280 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| For sentinel cohorts: Incidence and Severity of Adverse Events | For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo | Week 24 |
| For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline | Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders. | Week 12 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events | For fully expanded cohorts, including sentinel: for each dose/dosing regimen, incidence and severity of AEs, relationship of AEs to IP, and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. | Week 24 |
| Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders | For fully expanded cohorts, including sentinel: For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 24 | Week 24 |
References
Clinical Trials Gov: Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal InsertsOther trials to consider
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