NCT01543191已完成1 期
A Phase 1 Dose-escalation Study TO Evaluate the Safety and Tolerability of PUR118 and Placebo in Subjects With CF
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to determine whether PUR118 is safe and tolerable in a population of subjects with Cystic Fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant, non-lactating healthy female.
- •Age 18 to 55 years of age (inclusive) on day of signing informed consent.
- •Subject has a BMI of 17 or greater.
- •Subject has a confirmed diagnosis of cystic fibrosis documented by a compatible clinical or radiographic presentation, and definitive accepted lab and clinical criteria (e.g., sweat chloride > 60 mEq/L or 2 disease causing CFTR mutations) OR is regularly attending a Consultant led clinic where the diagnosis of Cystic Fibrosis is not in doubt.
- •Subject has an FEV1 ≥ 45% of predicted at screening.
- •Subject has an oxygen saturation >92% on room air as determined by pulse oximetry at screening.
- •Subject is a non-smoker or ex-smoker has not smoked for at least six months prior to screening.
- •Subject is otherwise medically stable without clinically significant abnormal screening results that depart from their usual baseline level of health as a subject with CF.
- •Must be willing and able to communicate in English and participate in the whole study.
- •Must provide written informed consent.
排除标准
- •Subject has unstable lung disease, as defined by a change in medical regimen during the preceding 2-weeks, or a significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse), or in the opinion of the Investigator, has had a decline in pulmonary status within the last year not considered a part of the usual, chronic progression of CF lung disease and part of their baseline health condition as a subject with CF.
- •Subject has had an exacerbation of respiratory symptoms within the past 30 days that required initiation of a new or altered respiratory therapy.
- •Subject had either an upper or lower respiratory illness within the 30 days prior to dosing days, or has symptoms from such an illness that have not resolved.
- •Subject has a history of lung transplantation.
- •Females of child bearing potential who are pregnant, or lactating. Females who are sexually active and either not surgically sterile or not willing to use an acceptable form of contraception
- •Clinically significant abnormal biochemistry, haematology or urinalysis not consistent with CF as judged by the Investigator
- •Failure to satisfy the Investigator of fitness to participate for any other reason.
研究组 & 干预措施
PUR118
Experimental
干预措施: PUR118 (Drug)
Placebo
Placebo Comparator
干预措施: PUR118 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 4-6 weeks
Changes in clinical signs and symptoms from physical examination and chest examination, changes in clinical safety laboratory tests, vital signs, spirometry, lung clearance index, 24-hour sputum weight and volume, oxygen saturation, ECG, telemetry, and adverse events.
次要结局
- Pharmacodynamics(36 hours)
研究者
研究点 (1)
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