An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions

Antiva Biosciences1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2018年12月21日最近更新: 2021年1月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 8
试验地点: 1
主要终点: Safety & Tolerability of ABI-1968 for the treatment of cHSIL

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 25 Years 至 50 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women, 25 to 50 years old.
•Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
•Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
•The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

排除标准

•Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
•HIV positive (tested at screening visit or within 3 months of screening visit).
•Resolution of visible CIN lesion prior to enrollment.
•ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
•History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.