NCT01389700终止2 期
A Randomized, Double-blind, Placebo-controlled Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of SAR279356 in Patients Hospitalized in Intensive Care Unit and on Mechanical Ventilation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL
研究概览
简要总结
Primary Objective:
- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation
Secondary Objectives:
- To determine the safety and tolerability of SAR279356
- To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356
- Exploratory efficacy of SAR279356 on prevention of bacterial infections
详细描述
Total study duration (from screening to last follow-up visit) is 91 days break down as follows:
- Screening: 1 day prior to dosing;
- Treatment period: one IV injection on Day 1;
- Follow-up period: 90 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR279356 dose 2
Experimental
SAR279356 dose 2, single administration
干预措施: SAR279356 (Drug)
SAR279356 dose 1
Experimental
SAR279356 dose 1, single administration
干预措施: SAR279356 (Drug)
Placebo
Placebo Comparator
Matching placebo, single administration
干预措施: placebo (Drug)
结局指标
主要结局
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL
时间窗: 90 days
次要结局
- Occurrence of infections(Up to 28 days)
- Dosage of human anti-human antibodies (HAHA)(90 days)
- Opsonophagocytic assay (OPA)(90 days)
- Opsonophagocytic killing assay (OPK)(90 days)
研究者
研究点 (6)
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