Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
- Registration Number
- NCT06491446
- Lead Sponsor
- Antiva Biosciences
- 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 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 (including up to 5 optional cohorts), each enrolling up to 8 participants. The optional cohorts may be enrolled in the study at the Sponsor's discretion based on emerging data from this study and the ABI-2280 program, in case additional dose/regimen ranging or dosing method exploration is indicated. A sentinel cohort may be repeated to evaluate the dosing regimen using a different method of administration. Additionally, any cohort may be paused or terminated, as recommended by the Safety Monitoring Committee (SMC) and/or per the Sponsor's discretion based on the emerging data from the preceding cohort or from the ABI-2280 program. Such decisions will be based on safety and/or benefit-risk considerations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Cohort 8 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo Experimental: Cohort 9 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo Experimental: Cohort 5 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo Experimental: Cohort 6 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo Experimental: Cohort 10 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo Experimental: Cohort 1 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo Experimental: Cohort 2 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo Experimental: Cohort 3 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo Experimental: Cohort 4 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo Experimental: Cohort 7 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo Experimental: Cohort 11 ABI-2280 Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo
- Primary Outcome Measures
Name Time Method For sentinel cohorts: Incidence and Severity of Adverse Events Week 24 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
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline Week 12 Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.
- Secondary Outcome Measures
Name Time Method For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events Week 24 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.
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders Week 24 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
Trial Locations
- Locations (16)
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
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
PARC Clinical Research, Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia