NCT00638365已完成1 期
A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 22
- 主要终点
- The Safety and Tolerability of a Single-dose of KB001.
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
详细描述
CF patients often have lung infections. Pseudomonas aeruginosa (Pa) is the most significant bacteria in CF, with up to 80% of CF patients eventually becoming infected. These patients are often treated with antibiotics with variable results. This study will examine the impact of a single-dose of an investigational drug, KB001, on Pa bacteria in the CF lung.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Confirmed diagnosis of CF based on the following criteria:
- •Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype
- •Age >/= 18 years of age with the potential for age 12 >/=
- •Screening Pa sputum culture
- •FEV1% predicted >/= 40 (based on Wang's equations for Males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)
排除标准
- •Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0
- •Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day
- •History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
- •Current cigarette smoker, history of drug addiction or alcohol abuse
- •Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
- •Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study
结局指标
主要结局
The Safety and Tolerability of a Single-dose of KB001.
时间窗: Day 28
Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.
次要结局
未报告次要终点
研究者
研究点 (22)
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