A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- The time to the remission of all influenza symptoms (hours)
研究概览
简要总结
The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:
- The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
- The safety of ZX-7101A in Chinese Adults patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 to ≤64 years of age at the time of signing the ICF.
- •Patients in the screening period met the following criteria: (1) rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; (2) fever ≥ 37.3℃ (axillary temperature) at screening; if taking antipyretics, axillary temperature ≥ 37.3℃ after taking the drug (more than 4 hours). (3) At least one of flu-related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever. (4) At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.
- •The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
排除标准
- •Patients with influenza virus infection requiring hospitalization.
- •High-risk population.
- •Bronchitis, pneumonia, pleural effusion or interstitial disease suspected by a clinician or confirmed by chest imaging [X-ray (anteroposterior or anteroposterior)/CT] and judged clinically significant by the investigator at screening.
- •Patients who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
- •Patients with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) > 10.0 × 109/L.
- •Patients with purulent sputum or suppurative tonsillitis.
- •Those who have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption.
- •Medications against influenza virus within 7 days prior to Screening.
研究组 & 干预措施
ZX-7101A low dose group
40 mg, tablet, single oral administration when the subject screened successfully
干预措施: ZX-7101A (Drug)
ZX-7101A high dose group
80 mg, tablet, single oral adminitration when the subject screened successfully
干预措施: ZX-7101A (Drug)
Placebo control
Analog tablet with no active ingredient, single oral administration when the subject screened successfully
干预措施: ZX-7101A (Drug)
结局指标
主要结局
The time to the remission of all influenza symptoms (hours)
时间窗: from accepting ZX-7101A until the 15 days after the first dosing
Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild);
次要结局
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0(from accepting ZX-7101A until the 15 days after the first dosing)