NCT00656097已完成2 期
A Randomized, Single-blind, Controlled, Monocentric Phase II Trial to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects
Crucell Holland BV2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects free of obvious health-problems or with stable condition
- •Male or female subjects aged ≥19 to ≤65 years
- •BMI between ≥18 and ≤30 kg/m2
排除标准
- •Prior history of active or passive rabies immunization
- •Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
- •History and/or family history of clinically significant immunodeficiency or auto-immune disease
- •Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
结局指标
主要结局
Safety and tolerability
时间窗: 42 days
次要结局
- Rabies virus neutralizing activity(42 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and AdolescentsRabiesNCT00708084Crucell Holland BV48
已完成
3 期
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.Transient InsomniaNCT03331042Sequential Medicine Ltd85
已完成
2 期
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy InfantsInfections, MeningococcalNCT05082285GlaxoSmithKline726
进行中（未招募）
2 期
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy AdolescentsMeningitis, MeningococcalNCT05087056GlaxoSmithKline312
已完成
3 期
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With NeuroblastomaHigh Risk NeuroblastomaNCT01041638National Cancer Institute (NCI)105