Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 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
- •Female or male subjects, at least 27 years old.
- •Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
- •Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
- •For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.
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, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
- •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 -Single Ascending Dose (SAD)
SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
干预措施: ABI-1968 (Drug)
Dose 2 -Single Ascending Dose (SAD)
SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
干预措施: ABI-1968 (Drug)
Dose 3 -Single Ascending Dose(SAD)
SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
干预措施: ABI-1968 (Drug)
Dose 4 -Single Ascending Dose(SAD)
SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
干预措施: ABI-1968 (Drug)
Dose 5 -Single Ascending Dose(SAD)
SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
干预措施: ABI-1968 (Drug)
Dose 1 - Multiple Ascending Dose(MAD)
MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
干预措施: ABI-1968 (Drug)
Dose 2 -Multiple Ascending Dose(MAD)
MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
干预措施: ABI-1968 (Drug)
Dose 3 -Multiple Ascending Dose(MAD)
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
干预措施: ABI-1968 (Drug)
Multiple Ascending Dose (MAD) Cohort Expansion
MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
干预措施: ABI-1968 (Drug)
Dose 4-Multiple Ascending Dose(MAD)
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
干预措施: ABI-1968 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
时间窗: SAD portion is 29 days/MAD portion is 84 days
Number of participants with Adverse Events related to treatment
次要结局
- Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.(SAD portion is 29 days/MAD portion is 84 days)
- Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.(SAD portion is 29 days/MAD portion is 84 days)