NCT01209793已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- •Normal vital signs after resting in a sitting position for 5 minutes:
- •Normal standard 12-lead ECG
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
- •Able to understand and complete study-related questionnaires
排除标准
- •Current or prior history of smoking
- •Any illness or condition that would adversely affect the subject's participation in this study
- •Hospitalization within 60 days of the screening visit
- •Any clinically significant abnormalities observed during the screening visit
- •History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
- •History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
- •History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
- •Known sensitivity to any of the components of the Investigational Product formulation
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
- •Any condition that would place the subject at risk, interfere with participation in the study
- •History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
- •Live/attenuated vaccinations within 12 weeks of screening or during the study
- •Any subjects with planned elective surgery
- •Sexually active men who are unwilling to utilize adequate contraception
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Baseline through end of study
次要结局
- PK profile(Baseline through end of study)
- Immunogenicity(Visits 2, 8, 10 and 12)
研究者
研究点 (1)
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