Phase 1b Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Infusion Trial of the Pharmacokinetics of Rhu-pGelsolin in Patients With Decreased Natural Gelsolin Levels
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
- Pharmacokinetics of plasma gelsolin
研究概览
简要总结
This study is designed to assess the pharmacokinetics and safety of an infusion of a single dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the Intensive Care Unit with documented low levels of natural gelsolin. It is believed that this drug will raise the gelsolin levels in these patients and decrease the probability that they will develop complications from their underlying disease such as organ system failure or death.
详细描述
This is a randomized, double-blind, placebo-controlled, ascending single dose of rhu-pGelsolin infusion study. Thirteen subjects (10 active and 3 placebo) will be dosed at 3 mg/kg and 5 subjects (3 active and 2 placebo) will be dosed at 6 mg/kg. In addition, twenty-two subjects (18 active and 4 placebo) will be dosed at 6 mg/kg per day for 3 days. The Data Safety Monitoring Committee (DSMC) and Steering Committee will review the preceding dose safety data, and agree the tolerability prior to the enrolment for next higher dose. Blood samples will be collected during 1 hour infusion through 72 hours post dose for PK assessment after each dose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Documented gelsolin level <100 mg/mL
- •Admission to ICU
- •Women of child-bearing age have a negative pregnancy test
- •Multiple Organ Failure score < 4
- •Catheter present through which blood samples can be taken
- •Written Informed Consent obtained
排除标准
- •Participation in other investigational treatment protocols
- •Patients <18 years of age
- •Patients who have a modified Multiple Organ Failure score of >=4
- •Patient, who in the opinion of the Principal Investigator, are unlikely to be in the ICU for >48 hours
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Low dose
3 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
干预措施: rhu-pGelsolin (Drug)
Mid-dose
6 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
干预措施: rhu-pGelsolin (Drug)
High dose
6 mg/kg of rhu-pGelsolin given a an IV infusion over 1 hour once a day for 3 days
干预措施: rhu-pGelsolin (Drug)
结局指标
主要结局
Pharmacokinetics of plasma gelsolin
时间窗: 72 hours
次要结局
- Adverse events and the development of anti-rhu-pGelsolin antibodies(3 months)
- Pharmacodynamics of sepsis biomarkers(72 hours)
- Clinical outcomes (mortality, duration of ICU stay, duration of ventilator support, duration of hospital stay)(28 days)