A Phase II Randomized, Placebo-controlled, Double-blind, Dose Controlled Trial in Patients Suffering From Early, Newly Developing Abdominal or Pulmonary Derived Septic Organ Dysfunction to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and to Estimate Efficacy of the New Humanized Monoclonal i.v. Administered Antibody CaCP29
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- InflaRx GmbH
- 入组人数
- 72
- 试验地点
- 11
- 主要终点
- Safety variables will be summarized using descriptive statistics based on adverse event collection
研究概览
简要总结
The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety variables will be summarized using descriptive statistics based on adverse event collection
时间窗: 28 days
Plasma Concentration of CaCP29
时间窗: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28
Pharmacokinetic measures include * Plasma concentration over time * Maximum observed concentration per infusion * Concentration measured immediately before next dosing * Area under the curve of plasma concentration per infusion * Mean concentration per infusion * Terminal phase half-life
Assess the pharmacodynamic (PD) effects of CaCP29 on the change from baseline in plasma concentrations of C5a
时间窗: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28
次要结局
- Anti-drug antibodies (ADA)(28 days or hospital discharge)
- Change in routine laboratory parameters as compared to baseline(Days 1, 2, 3, 4, 5, 8, 13, 28)
- Change in vital signs as compared to baseline(Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28)
- All-cause mortality rate(28 days)
- Change in ECG as compared to baseline(Days 2, 4, 8, 28)
- Morbidity(daily)
- Fluid balance(28 days or ICU discharge)