NCT06656026已完成2 期
A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Plasma concentrations of ZSP1273
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 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 subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form.
- •Subjects 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 72 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
- •Subjects with severe influenza virus infection；
- •Subjects 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；
- •Subjects with concurrent infections requiring antimicrobial therapy；
- •Subjects who are considered inappropriate for the study by the investigator.
研究组 & 干预措施
ZSP1273(Arm a)
Experimental
- ≥2 ，<6 year old，dose 1 QD；5day
- ≥6 ，<12 year old，dose 2 QD；5day
- ≥12，≤17 year old，dose 3 QD；5day
干预措施: ZSP1273 granules (Drug)
ZSP1273(Arm b)
Experimental
- ≥2 ，<6 year old，dose 4 QD；5day
- ≥6 ，<12 year old，dose 5 QD；5day
- ≥12，≤17 year old，dose 6 QD；5day
干预措施: ZSP1273 granules (Drug)
结局指标
主要结局
Plasma concentrations of ZSP1273
时间窗: DAY1~5
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(DAY1~29)
- Time to alleviation of influenza symptoms (duration of influenza)(DAY1~29)
- Percentage of subjects with virus titer detected(DAY1~29)
研究者
研究点 (1)
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