A Randomized, Double-blind, Placebo-controlled Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Multiple Doses AK0529 in Adult Hospitalized Subjects With Respiratory Syncytial Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 42
- 主要终点
- Incidence and severity of AE and SAE of subjects during the study period
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter, phase II study to be conducted in adults hospitalized with RSV infection in China. The main objectives of this study are to investigate the safety, pharmacokinetics and efficacy of AK0529 in adult RSV patients.
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)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active drug: AK0529 fasting
The participants will receive AK0529 twice daily for 5 days from D1 to D5.
干预措施: AK0529 (Drug)
Active drug: AK0529 with meal
The participants will receive AK0529 twice daily for 5 days from D1 to D5.
干预措施: AK0529 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of AE and SAE of subjects during the study period
时间窗: Baseline up to 28 days
An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect, or another important medical event.
次要结局
- Number of subjects with RSV VL values below the lower limit of quantitation (LLOQ) at each visit after treatment(Baseline up to 28 days)
- Number of participants who dropped out of the study due to AE(Baseline up to 28 days)
- Number of participants with vital sign abnormalities(Baseline up to 28 days)
- Area under the curve (AUCE, last) of RSV Viral Load from baseline to the last measurement(Baseline up to 28 days)
- Changes from baseline in the RSV VL (viral load) of subjects at each visit after treatment(Baseline up to 28 days)
- Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale(Baseline up to 28 days)
- Change from baseline in RiiQ symptoms of subjects at each visit after treatment measured by RiiQ questionnaire(Baseline up to 28 days)
- Changes from baseline in the total score of RSV Symptom of subjects at each visit after treatment using RSV Symptom Score Composite Scale(Baseline up to 28 days)
- Number of participants with laboratory examination abnormalities(Baseline up to 28 days)
- Number of participants with physical examination abnormalities(Baseline up to 28 days)
- Number of participants with ECG abnormalities(Baseline up to 28 days)
- Peak Plasma Concentration (Cmax)(Day 1, Day 5)
- Time to Maximum Plasma Concentration (Tmax)(Day 1，Day 5)
- Terminal Elimination Half-life (t½)(Day 1，Day 5)
- Apparent Clearance (CL/F)(Day 1，Day 5)
- Apparent Volume of Distribution (V[z]/F)(Day 1，Day 5)
- Area Under the Plasma Concentration-Time Curve From Time 0 to 12 (AUC[0-12])(Day 1，Day 5)
- Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞])(Day 1，Day 5)