A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
研究概览
简要总结
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.
详细描述
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male & Female volunteers
排除标准
- •Current clinically significant disease
- •Pregnant or nursing mother
- •Abnormal pulmonary function, nose or nasopharynx
研究组 & 干预措施
CT-P27 20mg/kg
CT-P27 will be administrated once in IV infusion.
干预措施: CT-P27 (Drug)
CT-P27 10mg/kg
CT-P27 will be administrated once in IV infusion.
干预措施: CT-P27 (Drug)
Placebo
Placebo will be administrated once in IV infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
时间窗: Three times a day from Day 1(the day after virus inoculation) to Day 9
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
次要结局
未报告次要终点