A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate the Safety and Efficacy of Different Oral Doses of TRX-100 and Standard of Care in Participants With Influenza
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence of AE/SAE
研究概览
简要总结
This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
详细描述
This is a multicenter, open-label, randomized, Phase 2a study to evaluate the safety, tolerability, and pilot efficacy of different oral doses of TRX-100 in otherwise healthy participants with mild to moderate influenza. The study will also evaluate PK of TRX-100 and its major active metabolite, TRX-101, following single oral doses of TRX-100.
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
- None
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
- •Participants with a diagnosis of influenza A or B virus infection
- •The time interval between the onset of symptoms and enrollment is 48 hours or less
- •Satisfactory baseline medical assessment by history and physical examination
排除标准
- •Positive test results for SARS-CoV-2 infection and/or respiratory syncytial virus infection
- •Participants with concurrent infections requiring systemic antimicrobial therapy
- •Participants with any serious or chronic underlying disease likely to affect study outcomes at the Investigator's discretion.
研究组 & 干预措施
TRX-100 Dose Level 1
Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100.
干预措施: TRX-100 (Drug)
TRX-100 Dose Level 2
Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100.
干预措施: TRX-100 (Drug)
Standard of Care (SOC)
Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug.
干预措施: Standard of Care (SOC) (Drug)
结局指标
主要结局
Incidence of AE/SAE
时间窗: up to Day 28
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Incidence of abnormal laboratory tests results
时间窗: Up to Day 28
Number of participants with abnormal laboratory tests results
Incidence of abnormal clinically significant ECG results
时间窗: Up to 28 days
Number of participants with abnormal physical examinations findings
时间窗: Up to 28 days
次要结局
- Change from baseline in the total score of 7 influenza symptoms(up to Day 15)
- Plasma Tmax(PK samples will be collected from Day 1 through Day 22.)
- Incidence of influenza-related complications(Up to 28 days)
- Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue)(Up to 28 days)
- Time to resolution of fever to <37 C (axillary temperature)(Up to 28 days)
- Percentage of participants with resolution of fever(Up to 28 days)
- Time needed to return to pre-influenza health status based on assessment of activities score(Up to 28 Days)
- Plasma Cmax(PK samples will be collected from Day 1 through Day 22.)
- Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100(PK samples will be collected from Day 1 through Day 22.)
- Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101(PK samples will be collected from Day 1 through Day 22.)
- Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)(PK samples will be collected from Day 1 through Day 22.)
- Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)(PK samples will be collected from Day through Day 22)
- Area under the plasma concentration-time curve from time zero extrapolated to infinity(PK samples will be collected from Day 1 through Day 22.)
- Area under the concentration-time curve extrapolated to infinity(PK samples will be collected from Day 1 through Day 22.)
- Terminal elimination half-life(PK samples will be collected from Day 1 through Day 22.)
- Terminal elimination half-life(PK samples will be collected from Day 1 through Day 22)
- Terminal elimination rate constant(PK samples will be collected from Day 1 through Day 22)
- Terminal elimination rate constant.(PK samples will be collected from Day 1 through Day 22)
- Apparent oral clearance (CL/F)(PK samples will be collected from Day 1 through Day 22)
- Apparent volume of distribution during the terminal phase(PK samples will be collected from Day 1 through Day 22.)
- Plasma Tmax(Time Frame: PK samples will be collected from Day 1 through Day 22.)
- Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101.(PK samples will be collected from Day 1 through Day 22.)