NCT02309320已完成1 期
A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.
Ablynx, a Sanofi company60 个研究点 分布在 14 个国家目标入组 53 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 60
- 主要终点
- Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
研究概览
简要总结
The primary objective of the study is to investigate the safety and tolerability of ALX-0171.
The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Days 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
- •Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
- •Subject has a positive RSV diagnostic test
- •Others as defined in the protocol
排除标准
- •Subject has history of wheezing
- •Subject is known to have significant comorbidities
- •Subject is known to be immunocompromised
- •Subject is suspected of having a clinically relevant infection other than RSV
- •Others as defined in the protocol
研究组 & 干预措施
Placebo
Placebo Comparator
Inhalation of Placebo during 3 consecutive days
干预措施: Placebo (Other)
ALX-0171
Experimental
Inhalation of ALX-0171 during 3 consecutive days
干预措施: ALX-0171 (Biological)
结局指标
主要结局
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
时间窗: 1 day before first dose to 14 days after first dose
次要结局
- Immunogenicity as measured by the concentration of anti-drug antibodies in serum(1 day before first dose to 14 days after first dose)
- Clinical activity as measured by the evaluation of the clinical response of the subjects(1 day before first dose to 14 days after first dose)
- Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum(Day 3)
- Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum(1 day before first dose to 14 days after first dose)
研究者
研究点 (60)
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