NCT03309358终止1 期
A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)
Synspira, Inc.2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年9月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults ≥18 and ≤50 years of age at screening.
- •Baseline FEV1 80-120% of predicted at Screening.
- •Oxygen saturation of ≥ 96% on room air as determined by pulse oximetry at Screening.
- •Screening laboratory tests within normal limits.
- •Female and Male subjects who are ≥18 years of age and a confirmed diagnosis of CF.
- •FEV1 >50% of predicted.
- •Oxygen saturation of ≥ 94% on room air as determined by pulse oximetry at Screening.
- •Stable CF pulmonary disease as judged by the Investigator.
排除标准
- •Any history of any form of lung disease or any systemic disease that may affect the lung or pulmonary function.
- •Former regular smoker or has smoked tobacco or cannabis products within the last 30 days.
- •Any history of any form of liver disease, renal disease, cardiac disease, hematologic disease, neurologic disease, atopy or any chronic condition.
- •Participation in one or more healthy subject studies within the prior 3 months.
- •Participation in a clinical trial involving receipt of an investigational product within the 30 days prior to screening.
- •Female subjects who are pregnant (a negative serum pregnancy test must be demonstrated at screening), have a positive pregnancy test, are lactating or who plan to become pregnant within 90 days after dosing.
- •Subjects requiring supplemental oxygen.
- •Hemoptysis of >5 mL within 12 weeks of screening.
- •Listed for organ transplantation.
研究组 & 干预措施
Inhaled SNSP113
Experimental
干预措施: Inhaled SNSP113 (Drug)
Inhaled Placebo
Placebo Comparator
干预措施: Inhaled Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 8 days
To determine the incidence of treatment related adverse events.
Spirometry
时间窗: 8 days
To assess change from baseline spirometry.
Pulse Oximetry
时间窗: 8 days
To assess change in baseline pulse oximetry
次要结局
- Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)(Days 1, 2 and 8)
- Area under concentration-time curve from time zero extrapolated to infinity (AUC)(Days 1, 2 and 8)
研究者
研究点 (2)
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