Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

赞助:

合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

September 25, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 15, 2018

预计主要完成日期

June 1, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Safety & Tolerability of ABI-1968 for the treatment of cHSIL[ Time Frame: 42 days ]

Number of Adverse Events related to treatment

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.[ Time Frame: 42 days ]
Plasma concentrations of ABI-1968 over time

描述性信息

简略标题 ^ICMJE

Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

正式标题 ^ICMJE

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

简要概况

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.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 1

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Sequential Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Topical ABI-1968
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

研究工具

Experimental: Dose 1
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 2
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 3
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 4
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 5
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 1, 2019

预计主要完成日期

June 1, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Women, 25 to 50 years old. 2. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. 3. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible. 4. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening. Exclusion Criteria: 1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females. 2. HIV positive (tested at screening visit or within 3 months of screening visit). 3. Resolution of visible CIN lesion prior to enrollment. 4. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer. 5. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

性别

参与研究的性别:

Female

年龄

最小年龄：25 Years ，最大年龄：50 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

South Africa

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Antiva Biosciences

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

August 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名