A Randomised, Double-blind, Placebo Controlled, First-in-human Study to Investigate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of SLN360 in Subjects With Elevated Lipoprotein(a)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).
详细描述
This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN360 after single ascending s.c. doses and multiple doses in healthy male and female subjects.
Up to 9 cohorts of 88 patients with elevated Lp(a) will be enrolled. Each patient will receive single or multiple doses of SLN360 or placebo given by subcutaneous (s.c) injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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
30 mg
干预措施: SLN360 (Drug)
Placebo
干预措施: Placebo (Drug)
100 mg
干预措施: SLN360 (Drug)
300 mg
干预措施: SLN360 (Drug)
600 mg
干预措施: SLN360 (Drug)
900 mg
干预措施: SLN360 (Drug)
100 mg multi dose
干预措施: SLN360 (Drug)
200 mg multi dose
干预措施: SLN360 (Drug)
300 mg multi dose
干预措施: SLN360 (Drug)
600 mg multi dose
干预措施: SLN360 (Drug)
Placebo multi dose
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Day 201
safety and tolerability will be reported separately following multiple-dose administration.
次要结局
- Pharmacokinetic: area under the plasma concentration (AUC)(Day 150 and Day 201)
- Pharmacokinetic: peak plasma concentration (Cmax)(Day 150 and Day 201)
- Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)(Day 150 and Day 201)
- Pharmacodynamic: Change in Lp(a)(Day 150 and Day 201)