A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Celltrion
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Time to Resolution of Influenza Symptoms and Fever
研究概览
简要总结
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.
详细描述
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects between the ages of 19 and 64 years, both inclusive
- •Diagnosed with influenza A at screening using rapid influenza diagnostic test
- •Onset of influenza symptoms and fever is within 48 hours at screening
- •At least 2 of symptoms (moderate to severe in intensity)
- •≥38.0'C body temperature at screening
排除标准
- •Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
- •Positive influenza B or A+B infection
研究组 & 干预措施
CT-P27 90 mg/kg
CT-P27 will be administrated once in IV infusion.
干预措施: CT-P27 90 mg/kg (Drug)
CT-P27 45mg/kg
CT-P27 will be administrated once in IV infusion.
干预措施: CT-P27 45 mg/kg (Drug)
Placebo
Placebo will be administrated once in IV infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Resolution of Influenza Symptoms and Fever
时间窗: Twice a day (Morning and Evening) from Day 1 to Day 8
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8)
次要结局
未报告次要终点