NCT02460016终止1 期
A Phase 1b, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of AK0529 in Infants Hospitalized With Respiratory Syncytial Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).
详细描述
This is a open-label Phase 1b study to evaluate the safety, tolerability, pharmacodynamics and Pharmacokinetics of AK0529 in hospitalized RSV infected infants age from 1 to 24 months.
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
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
- •Diagnosis of RSV infection by virological.
- •Subject must weigh >3 kg at screening.
- •Must have provided written informed consent for the subject to participate.
- •For patients aged <12 months, and occipitofrontal head circumference (OFHC) within the normal range for age and gender.
排除标准
- •The subject has taken, is currently taking or requires any restricted medications.
- •Subject is known to be HIV-positive (or the mother, if the potential subject is a child aged <6 months).
- •Participation in an investigational drug or device study within 30 days prior to the date of screening.
- •Requires vasopressors or inotropic support at the time of enrollment.
- •Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
- •Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrollment.
- •Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia).
- •Left to right shunt meriting corrective therapy.
研究组 & 干预措施
AK0529
Experimental
AK0529 pellets
干预措施: AK0529 (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: Baseline through 7 days post administration
次要结局
- Pharmacokinetics parameters, including time to maximum concentration and half-time(Baseline through 3 days post administration)
- Pharmacokinetics parameters, including maximum and minimum of drug concentration(Baseline through 3 days post administration)
- Pharmacokinetics parameters, including area under concentration-time curves (AUC)(Baseline through 3 days post administration)
研究者
研究点 (1)
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