A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 39
- 主要终点
- For sentinel cohorts: Incidence and Severity of Adverse Events
研究概览
简要总结
This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.
详细描述
This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.
Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind masking
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex, 25 to 55 years of age
- •Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
- •Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.
排除标准
- •History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
- •Any clinically significant immune suppressing condition
- •History or current diagnosis of cervical cancer, suspected or confirmed
- •Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.
研究组 & 干预措施
Experimental: Cohort 7
Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 8
Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 10
Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 2
Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 3
Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 1
Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 4
Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 5
Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 6
Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 9
Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo
干预措施: ABI-2280 (Drug)
Experimental: Cohort 11
Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo
干预措施: ABI-2280 (Drug)
结局指标
主要结局
For sentinel cohorts: Incidence and Severity of Adverse Events
时间窗: Week 24
For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline
时间窗: Week 12
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.
次要结局
- For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events(Week 24)
- Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders(Week 24)