KCT0002211招募中未知
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
- 未知
- 状态
- 招募中
- 发起方
- Celltrion
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •Written informed consent.
- •Onset of illness no more than 48 hours prior to the planned administration of study drug.
- •Diagnosed with influenza A at screening.
排除标准
- •Positive influenza B or invluenza A+B infection
- •Previous exposure to any anti-influenza monoclonal antibody therapy including CT-P27 prior to study drug administration.
- •Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug.
- •Immunized against influenza with live attenuated or inactivated virus vaccine within 21 days prior to the administration of study drug.
- •Abnormal pulmonary, renal, cardiac function
- •Pregnant or nursing mother
研究者
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