NCT05502367

A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia

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: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Antiva Biosciences · Industry
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	ABI-2280 Vaginal Tablet/Insert	Vaginal Tablet

Timeline

• Start date: 2022-09-10
• Primary completion: 2025-10-27
• Completion: 2025-10-27
• First posted: 2022-08-16
• Last updated: 2026-02-19

Locations

7 sites across 3 countries: Australia, Peru, South Africa