Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (Nivolumab) in Participants With Severe Sepsis or Septic Shock.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 32
- 主要终点
- Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths
研究概览
简要总结
A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Men and women ages ≥ 18 years old
- •Documented or suspected infection
- •Severe sepsis or septic shock for at least 24 hours
- •Sepsis-induced immunosuppression
- •In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours
排除标准
- •Previous episode of severe sepsis or septic shock with ICU admission during the current hospitalization
- •Autoimmune disease
- •Organ or bone marrow transplant
- •Cancer treatment in the past 6 weeks
- •Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic hepatitis B virus (HBV) infection and not on treatment
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab 2
Dose 2
干预措施: Nivolumab (Biological)
Nivolumab 1
Dose 1
干预措施: Nivolumab (Biological)
结局指标
主要结局
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths
时间窗: Screening, day -1, day 1 and subsequent days after, up to 90 days
Composite of Vital Signs and Electrocardiogram (ECG)
时间窗: Screening up to 90 days (Discharge)
Includes body temperature, respiratory rate, blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.
Peak Nivolumab Serum Concentration (Cmax)
时间窗: Day 1 and subsequent days after, up to 90 days
Participants peak nivolumab serum concentration
Trough Nivolumab Serum Concentration (Cmin)
时间窗: Day 1 and subsequent days after, up to 90 days
Participant trough nivolumab serum concentration
Time of Maximum Observed Concentration (Tmax)
时间窗: Day 1 and subsequent days after, up to 90 days
Participant observed time of maximum concentration
Average Nivolumab Serum Concentration (Cavg)
时间窗: Day 1 and subsequent days after, up to 90 days
Participant average nivolumab serum concentration
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
时间窗: Day 1 and subsequent days after, up to 90 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration
Total Clearance (CLT)
时间窗: Day 1 and subsequent days after, up to 90 days
Total clearance of serum concentration of nivolumab
Volume of Distribution (Vd)
时间窗: Day 1 and subsequent days after, up to 90 days
Vlume of distribution of nivolumab serum concentration
Half-life (T1/2)
时间窗: Day 1 and subsequent days after, up to 90 days
Half-Life of nivolumab derived from serum concentration
次要结局
- Number of Participants With Detectable Anti-nivolumab Antibodies(Baseline and subsequent days after, up to 90 days)
- Receptor Occupancy(Day 1 and up to day 90 (discharge))
- Number of Participants With Any Detectable Anti-drug Antibodies(Baseline and subsequent days after, up to 90 days)