NCT00496821已完成2 期
A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Alnylam Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2007年7月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Safety and tolerability of intranasal ALN-RSV01 versus placebo, administered in a multiple-dose schedule (once daily for 5 days) to healthy adult volunteers experimentally inoculated with respiratory syncytial virus
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with 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
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Availability for the required study period (including the inpatient phase, ability to comply with study requirements and attend follow-up study visits
- •Able to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
- •Good general health status as determined by a screening evaluation no greater than 120 days but not less than 14 days prior to enrollment and admission to the research unit
- •Low titers of RSV neutralizing antibody measured during screening.
排除标准
- •Significant acute or chronic, uncontrolled medical illness
- •Presence of household member or close contact to someone who:
- •Is less than three(3) years of age
- •Has a known immunodeficiency
- •Is receiving immunosuppressant drugs
- •Is undergoing or soon to undergo cancer chemotherapy within 28 days of enrollment
- •Has diagnosed emphysema, chronic obstructive pulmonary disease(COPD), or severe lung disease
- •Is elderly and residing in a nursing home, or
- •Has received an organ transplant
- •Females are not eligible for this study
- •Evidence of or history of drug or alcohol abuse (within the past 6 months) or positive urine drug or alcohol screen
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Safety and tolerability of intranasal ALN-RSV01 versus placebo, administered in a multiple-dose schedule (once daily for 5 days) to healthy adult volunteers experimentally inoculated with respiratory syncytial virus
时间窗: 28 days
次要结局
- Determining the impact of ALN-RSV01 on symptoms of RSV infection, RSV infection rate based upon measures of viral load, and understanding the potential antiviral activity of ALN-RSV01(28 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common ColdNasal CongestionNCT05365789Church & Dwight Company, Inc.220
已完成
不适用
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal SurgeryOtorhinolaryngologic Surgical ProceduresLaser TherapyNCT03086265Stanford University20
已完成
1 期
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese SubjectsHealthyNCT02857777Janssen Research & Development, LLC37
已完成
不适用
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/ConditionsSinusitisUpper Respiratory InfectionsColdsRhinitisNCT06498843YSLab89
Unknown
1 期
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy SubjectsSedationNCT03293277Jiangsu HengRui Medicine Co., Ltd.48