A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 77
- 主要终点
- 12-Lead ECGs
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)
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
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness
排除标准
- •Prematurity
- •Receiving invasive endotracheal mechanical ventilation
- •Poorly functioning gastrointestinal tract
- •Anticipated to be discharged from the hospital in <24 hours from the time of randomization
- •Prior exposure to palivizumab
研究组 & 干预措施
ALS-008176 Single Dose
Single dose of ALS-008176 administered orally as a suspension
干预措施: ALS-008176 (Drug)
Placebo Single Dose
Single dose of placebo administered orally as a suspension
干预措施: Placebo (Drug)
ALS-008176 Multiple Doses
Multiple doses of ALS-008176 administered orally as a suspension
干预措施: ALS-008176 (Drug)
Placebo Multiple Doses
Multiple doses of placebo administered orally as a suspension
干预措施: Placebo (Drug)
结局指标
主要结局
12-Lead ECGs
时间窗: Baseline through 6 days post-dose
Physical Examinations
时间窗: Baseline through 6 days post-dose
Clinical Laboratory Results
时间窗: Baseline through 6 days post-dose
Adverse Events
时间窗: Baseline through 6 days post-dose
Vital Signs
时间窗: Baseline through 6 days post-dose
次要结局
- RSV viral RNA concentrations in nasal aspirates(Baseline through 6 days post-dose)
- Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)(Baseline through 6 days post-dose)
- Emergence of resistance(Baseline through 6 days post-dose)
- Pharmacokinetic parameters, including maximum and minimum drug concentrations(Baseline through 6 days post-dose)
- Pharmacokinetic parameters, including time to maximum concentration and half-life(Baseline through 6 days post-dose)
- Pharmacokinetic parameters, including area under concentration-time curves (AUCs)(Baseline through 6 days post-dose)