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

NCT05502367 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-19

No results posted yet for this study

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

DRUG

ABI-2280 Vaginal Tablet/Insert

Vaginal Tablet

Sponsors & Collaborators

  • Antiva Biosciences

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-10
Primary Completion
2025-10-27
Completion
2025-10-27

Countries

  • Australia
  • Peru
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502367 on ClinicalTrials.gov