NCT01483911已完成1 期
Phase I, Single-centre, Randomised, Placebo-controlled, Double-blinded Study, With Single Ascending Dose and Multiple Dose at Maximum Tolerated Dose, Evaluating the Safety, Tolerability and Pharmacokinetics of ALX-0171, Administered by Pulmonary Inhalation, in Healthy Male Volunteers
Ablynx, a Sanofi company1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- number of treatment-emergent adverse events
研究概览
简要总结
ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The purpose of this first-in-man study is to determine the safety, tolerability and pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in healthy male volunteers.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking healthy male volunteers, aged 18-55 years
- •Good health condition, as determined by medical history, physical examination and clinical laboratory testing
- •Forced expiratory volume in 1 second (FEV1) ≥ 90% of predicted value
- •Diffusing capacity of the lung for CO (DLCO) ≥ 85% of predicted value
- •Normal chest X-Ray (anteroposterior and lateral view)
- •Minimum weight of 70.0 kg, minimum height of 1m70, body mass index between 18.0 and 30.0 kg/m²
排除标准
- •Current smokers, or ex-smokers abstinent from tobacco for less than one year
- •History or presence of atopy or pulmonary non-specific hyperreactivity
- •Positive bronchial challenge test
- •Symptomatic viral infection, or suspicion thereof (including rhinitis) in last 14 days prior to dosing
- •Signs of active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, in the last 14 days prior to dosing
结局指标
主要结局
number of treatment-emergent adverse events
时间窗: until 1 month after last study drug administration
次要结局
- plasma concentration of ALX-0171(from predose until 5 days after study drug administration)
研究者
研究点 (1)
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