NCT03677960终止1 期
Open-Label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Antiva Biosciences1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年12月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
研究概览
简要总结
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and 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
- 27 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
- •Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
- •History of cancer involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years
- •History of genital herpes with > 3 outbreaks per year.
- •Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
研究组 & 干预措施
Dose 1 - Multiple Ascending Dose(MAD)
Experimental
Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
干预措施: Topical ABI-1968 cream (Drug)
Dose 2 - Multiple Ascending Dose(MAD)
Experimental
Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
干预措施: Topical ABI-1968 cream (Drug)
Dose 3 - Multiple Ascending Dose(MAD)
Experimental
Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
干预措施: Topical ABI-1968 cream (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
时间窗: MAD portion is 84 days
Number of participants with Adverse Events related to treatment
次要结局
- Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.(MAD portion is 84 days)
研究者
研究点 (1)
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