Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491446
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
Sponsor:
Antiva Biosciences
Organization:
Antiva Biosciences
Study Overview
Official Title:
A Randomized Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 benefitrisk of a given dosedose regimen
Detailed Description:
This is a randomized double-blind placebo-controlled Phase 1b2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None