NCT04033406已完成1 期
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with abnormalities in vital signs.
研究概览
简要总结
This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male or Female age 18 to < 65 years
- •Body mass index (BMI) of 18.0 kg/m^2 to 32.0kg/m^2
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- •History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization.
- •Fever-like illness within 5 days of randomization.
- •History or clinical evidence of conditions considered high risk for developing influenza-related complications.
研究组 & 干预措施
VIR-2482
Experimental
VIR-2482
干预措施: VIR-2482 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with abnormalities in vital signs.
时间窗: Up to 12 months post-dose
Number of participants with abnormalities in clinically significant laboratory findings.
时间窗: Up to 12 months post-dose
Number of participants with abnormalities in electrocardiogram (ECG).
时间窗: Up to 12 months post-dose
Number of participants with treatment-emergent adverse events.
时间窗: Up to 12 months post-dose
次要结局
- Incidence of anti-drug antibody (ADA) to VIR-2482(Up to 12 months post-dose)
- Concentrations of VIR-2482 in serum(Up to 12 months post-dose)
- Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482(Up to 12 months post-dose)
研究者
研究点 (1)
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