A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
研究概览
简要总结
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
详细描述
This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.
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 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously healthy
- •Age 24 months and younger at the time of randomization
- •Gestational age of 36 weeks gestation and older
- •Randomization within 24 hours after hospitalization
- •Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization
排除标准
- •Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
- •Required intubation for ventilatory support
- •Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
- •Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- •Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
- •Mechanical ventilation at any time prior to the onset of the current RSV infection
- •Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
- •Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
- •Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
- •Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- •Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
结局指标
主要结局
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
时间窗: Day 2 and Day 30
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
时间窗: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
时间窗: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
时间窗: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
次要结局
- To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30(Day 30)
- To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0(Immediately before dosing on Day 0)