NCT07229820进行中（未招募）3 期
A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo in Children 12-17 Years Old With Acute Uncomplicated Influenza A
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2025年11月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Time to Alleviation of Symptoms
研究概览
简要总结
This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
- •Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
- •Participants with a diagnosis of influenza virus infection confirmed by all of the following:
- •Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;
- •The time interval between the onset of symptoms and enrollment is 48 hours or less;
- •Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present
排除标准
- •Participants with severe influenza virus infection；
- •Participants with any medical history in gastrointestinal that interferes with the absorption of drugs；
- •Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；
- •Have received any other investigational products within 3 months prior to dosing；
- •Positive urine pregnancy test；
- •Participants with concurrent infections requiring antimicrobial therapy；
- •Participants who are considered inappropriate for the study by the investigator.
研究组 & 干预措施
ZSP1273
Experimental
干预措施: ZSP1273 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Alleviation of Symptoms
时间窗: DAY1~DAY15
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(DAY1~DAY15)
- Plasma concentrations of ZSP1273(DAY1~DAY15)
研究者
研究点 (1)
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