A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
研究概览
简要总结
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.
The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ages > 7 years old
- •Diagnosis of CF as evidenced by sweat chloride test and/or genetic mutation testing
- •Sputum SA CFUs > 10,000 per mL
- •Ability to expectorate sputum
- •Ability to tolerate nasal lavage and collection of breath condensate
- •Willing to practice reliable birth control measures during the entire study period, if subject is of childbearing potential
- •Informed consent obtained from subject or legal guardian, and assent if appropriate
排除标准
- •Burkholderia cepacia in sputum
- •Subjects who have had changes to their treatment regimen for CF in the past 6 weeks
- •Subjects can be screened 6 weeks after IV antibiotic completion
- •Subjects can be screened 7 days after oral antibiotic completion
- •Received an investigational drug within 30 days of study entry
- •Received any immune globulin or blood product within 30 days of study entry
- •History of hypersensitivity to immune globulin preparations
- •Undergoing any type of dialysis or expected to start dialysis within 30 days
- •Pregnant or nursing females
- •Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
结局指标
主要结局
To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
次要结局
- To evaluate the biologic and clinical effects of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs on:
- Changes in bacterial load of SA in sputum as determined by colony counts
- Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
- Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
- Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%