A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants (MEDI8897 1b)
2018年9月18日 更新者：MedImmune LLC
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.
研究概览
详细说明
This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children.
The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines.
These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy.
Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.
研究类型
介入性
注册 (实际的)
151
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Cape Town、南非
- Research Site
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East London、南非
- Research Site
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Johannesburg、南非
- Research Site
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Pretoria、南非
- Research Site
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Santiago、智利
- Research Site
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Valdivia、智利
- Research Site
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California
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Anaheim、California、美国
- Research Site
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Ontario、California、美国
- Research Site
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New York
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Syracuse、New York、美国
- Research Site
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Ohio
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Cleveland、Ohio、美国
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South Carolina
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Charleston、South Carolina、美国
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Utah
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Saint George、Utah、美国
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Wisconsin
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Marshfield、Wisconsin、美国
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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 1年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
- Infants who are entering their first RSV season at the time of screening
Key Exclusion Criteria:
- Gestational age < 32 weeks 0 days and >34 weeks 6 days
- Meets AAP or other local criteria to receive commercial palivizumab
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
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：预防
- 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 |
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安慰剂比较：Placebo
Participants will receive placebo intramuscularly.
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Participants will receive placebo intramuscularly.
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实验性的：MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
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Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
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实验性的：MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
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Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
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实验性的：MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
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Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
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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 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
大体时间：From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897.
TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.
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From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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Number of Participants With Treatment-Emergent Adverse Events of Special Interest
大体时间：From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor.
The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia.
Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.
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From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
大体时间：From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
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Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs.
Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.
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From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Maximum Observed Serum Concentration (Cmax) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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The Cmax is the maximum observed serum concentration of MEDI8897.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
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Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
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Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Terminal Elimination Half Life (t1/2) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Extravascular Clearance (CL/F) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Extravascular Volume of Distribution (Vz/F) of MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
大体时间：Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
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A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline.
Titers greater than or equal to 50 were considered positive.
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Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
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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。
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 (实际的)
2015年1月13日
初级完成 (实际的)
2016年9月28日
研究完成 (实际的)
2016年9月28日
研究注册日期
首次提交
2014年10月17日
首先提交符合 QC 标准的
2014年11月10日
首次发布 (估计)
2014年11月14日
研究记录更新
最后更新发布 (实际的)
2018年9月19日
上次提交的符合 QC 标准的更新
2018年9月18日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
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.