Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-04 @ 3:57 AM
Study NCT ID:
NCT05502367
Status:
RECRUITING
Last Update Posted:
2024-09-24
First Post:
2022-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia
Sponsor:
Antiva Biosciences
Organization:
Study Overview
Official Title:
An Open-Label Single and Multiple-dose, Study to Evaluate Safety, Tolerability and Efficacy of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Squamous Intraepithelial Lesions
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 an open-label study to evaluate the safety, tolerability, and efficacy of ABI-2280 in participants with cervical squamous intraepithelial lesions. This study is divided into 2 parts - Part A and Part B.
Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts.
Participants will self-administer ABI-2280.
Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts.
Participants will self-administer ABI-2280.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: