A Phase I Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6002 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.
详细描述
Ebola hemorrhagic fever (EHF) is a rare human disease caused by Ebola Virus (EBOV), a filamentous single-stranded, negative-sense RNA virus. Since 1976 several Ebolavirus outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these outbreaks traced to single EBOV species; EBOV-Z. No effective therapy is currently available for Ebolavirus.
AVI-6002 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically target viral messenger RNA encoding 2 Ebolavirus proteins thought to be important in viral replication and host immune suppression. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-6002 in healthy human subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female and between the ages of 18 and 50 years in good general health
- •Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
- •Volunteers must be willing to undergo a urine screen for drugs of abuse
排除标准
- •Pregnancy or breastfeeding.
- •Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
- •Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
AVI-6002
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
干预措施: AVI-6002 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 28 Days
The frequency and severity of adverse events will be monitored through 28 days post administration.
次要结局
- Drug concentration in plasma(28 days)
- Drug concentration in urine(28 days)