NCT07357051招募中3 期
A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza
Joincare Pharmaceutical Group Industry Co., Ltd0 个研究点目标入组 177 人开始时间: 2025年11月7日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 177
研究概览
简要总结
The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
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
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients within the specified age range.
- •Clinical presentation consistent with influenza, confirmed by a positive local rapid test or central laboratory PCR test.
- •Presentation for treatment within the early symptomatic phase of influenza illness.
- •Presence of fever and at least one respiratory symptom.
- •Ability to swallow oral suspension.
- •Parent/guardian and patient (as age-appropriate) able to provide informed consent/assent.
排除标准
- •Clinical signs suggestive of severe or complicated influenza infection
- •requiring inpatient management.
- •Presence of a concurrent bacterial infection requiring systemic therapy.
- •Significant immunocompromised, or severe/uncontrolled comorbid conditions.
- •History of hypersensitivity to any component of the investigational products.
- •Use of prohibited medications (including other anti-influenza antivirals) within a specified period prior to enrollment.
- •Recent participation in another interventional clinical trial.
- •Any condition that, in the opinion of the investigator, would jeopardize patient safety or compliance with the study protocol.
研究者
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