Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
2021年9月10日 更新者：MedImmune LLC
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
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).
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
31
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 2年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Motavizumab, 3 mg/kg as a single intravenous dose
Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
|
|
实验性的：Motavizumab, 15 mg/kg as a single intravenous dose
Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
|
|
实验性的：Motavizumab, 30 mg/kg as a single intravenous dose
Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
其他名称：
|
|
安慰剂比较：Placebo, as a single intravenous dose
Placebo, as a single intravenous dose administered on Day 0
|
Single dose of placebo administered intravenously (in the vein) on Day 0
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
大体时间：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
|
From the start of treatment to 30 days after dosing
|
|
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
大体时间：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
|
From the start of treatment to 30 days after dosing
|
|
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
大体时间：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
|
From the start of treatment to 30 days after dosing
|
|
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
大体时间：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).
|
Day 2 and Day 30
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
大体时间：Immediately before dosing on Day 0
|
The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing).
Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
|
Immediately before dosing on Day 0
|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
大体时间：Day 30
|
The serum anti-motavizumab antibody titers were measured in subjects on Day 30.
Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
|
Day 30
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Genevieve A Losonsky, MD、MedImmune LLC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年3月1日
初级完成 (实际的)
2005年1月1日
研究完成 (实际的)
2005年1月1日
研究注册日期
首次提交
2005年9月13日
首先提交符合 QC 标准的
2005年9月13日
首次发布 (估计)
2005年9月19日
研究记录更新
最后更新发布 (实际的)
2021年10月8日
上次提交的符合 QC 标准的更新
2021年9月10日
最后验证
2006年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Motavizumab的临床试验
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