NCT01872065已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects, 18-55 years of age
- •Be a non-smoker
排除标准
- •History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment.
- •Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.
- •Currently uses and/or has a history of alcohol and/or drug abuse < 12 months from screening.
- •Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
研究组 & 干预措施
ARC-520
Experimental
Single dose, intravenous administration of ARC-520.
干预措施: ARC-520 (Drug)
Normal Saline
Placebo Comparator
Single dose, intravenous administration of Normal Saline
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520
时间窗: One month
The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group.
次要结局
- To evaluate the pharmacokinetics of ARC-520 at different dose concentrations(2 days)
研究者
研究点 (1)
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