A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 74
- 主要终点
- To investigate the improvement in reducing the duration of illness compared to placebo.
研究概览
简要总结
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High dose of KT07 capsule
It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).
干预措施: KT07 Capsule (Drug)
Low dose of KT07 capsule
It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).
干预措施: KT07 Capsule (Drug)
Low dose of KT07 capsule
It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).
干预措施: Placebo (Other)
Placebo
It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.
干预措施: Placebo (Other)
结局指标
主要结局
To investigate the improvement in reducing the duration of illness compared to placebo.
时间窗: Up to 19 days
Duration of illness is defined as: the length of time to alleviation of all symptoms. The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.
次要结局
- The reduction in duration of alleviation of individual symptom(Up to 19 days)
- Quality of life assessment(Up to 19 days)