NCT01808469已完成1 期
A Randomized, Double Blind, Placebo-controlled, Pharmacokinetics/Pharmacodynamics-guided, Phase I Study in Healthy Volunteers Given Escalating, Single Intravenous Doses of NI-0101 in the Absence and Then in the Presence of a Systemic Lipopolysaccharide Challenge.
Light Chain Bioscience - Novimmune SA2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Safety and tolerability of NI-0101 in healthy male/female subjects
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition its effects on some inflammatory parameters will be measured in presence or absence of lipopolysaccharide stimulation.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 18 and 40 years old (inclusive) having a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), able to adhere to study protocol requirements and having signed informed consent.
排除标准
- •Any abnormal past or present clinically relevant medical history or any relevant abnormal laboratory parameters at screening that will prevent to consider the volunteers as healthy for the study.
结局指标
主要结局
Safety and tolerability of NI-0101 in healthy male/female subjects
时间窗: Up to 8 weeks
* 12 lead ECG * Vital signs * Physical examination * Adverse events * Routine laboratory assessments during 8 weeks post administration.
次要结局
- Pharmacodynamic parameters of NI-0101(Up to 8 weeks)
- Pharmacokinetic parameters of NI-0101(Up to 8 weeks)
研究者
研究点 (2)
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