An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency of adverse events
研究概览
简要总结
The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers.
详细描述
This is an open-label study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of four formulations of LY03009 (F1, F2, F3, F4) after a single intramuscular injection.
Approximately 40 healthy subjects are planned to be enrolled in this study and assigned to four cohorts (F1, F2, F3, F4) sequentially, 10 subjects per group at a fixed dose of 112 mg for F1~F3 and 224 mg for F4. Each subject will receive only one dose in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Formulation 1
a single dose of LY03009 F1
干预措施: LY03009 F1 (Drug)
Formulation 2
a single dose of LY03009 F2
干预措施: LY03009 F2 (Drug)
Formulation 3
a single dose of LY03009 F3
干预措施: LY03009 F3 (Drug)
Formulation 4
a single dose of LY03009 F4
干预措施: LY03009 F4 (Drug)
结局指标
主要结局
Frequency of adverse events
时间窗: From screening up to day 161
Frequency of adverse events. Apply to cohort F4.
次要结局
- Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009(From screening up to day 161)
- Maximum (peak) plasma concentration (Cmax) of LY03009(From screening up to day 161)
- Apparent clearance (CL/F) of LY03009(From screening up to day 161)
- Time to maximum plasma concentration (Tmax) of LY03009(From screening up to day 161)
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009(From screening up to day 161)
- Apparent volume of distribution (Vz/F) of LY03009(From screening up to day 161)
- Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009(From screening up to day 161)
- Terminal elimination half-life (t1/2) of LY03009(From screening up to day 161)
- Terminal elimination rate constant (λz) of LY03009(From screening up to day 161)
- Mean residence time (MRT) of LY03009(From screening up to day 161)