NCT00914433撤回1 期
A Phase 1,Randomized, Double--blind, Placebo-controlled Study Assessing the Safety and Tolerability, the Pharmacodynamics and Pharmacokinetics of Single-ascending and Repeated Doses of Inhaled TPI 1100 in Healthy Subjects
Syntara0 个研究点开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Airway-specific and general safety and tolerability.
研究概览
简要总结
This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D & 7A in blood and in sputum.
详细描述
Study was not initiated and terminated before start-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female volunteers aged 18 to 55 years inclusive
- •Screening/baseline FEV1 greater than 90% predicted,
- •Body mass index (BMI) of 19 to 28 inclusive,
- •Clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the Investigator
排除标准
- •Airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems,
- •Breast-feeding or pregnancy,
- •Positive tests for smoking tobacco, alcohol, hepatitis B-surface antigen, hepatitis C antibody, and HIV at screening,
- •History of serious adverse reaction to any drugs,
研究组 & 干预措施
TPI 1100
Experimental
Drug to be given by inhalation.
干预措施: TPI 1100 (Drug)
结局指标
主要结局
Airway-specific and general safety and tolerability.
时间窗: 24 hours post-dose and on Day 4
次要结局
- Effect on mRNA(24 hrs post-dose and on Day 4)
研究者
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