A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-3403 in Healthy Volunteers and Subjects With Elevated LDL-C
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Number of participants with abnormal laboratory tests results
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD.
详细描述
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C. The study will be performed in 2 phases: SAD and MAD.
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 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
SGB-3403(SAD)
干预措施: SGB-3403 (Drug)
placebo(SAD)
干预措施: Placebo (Other)
SGB-3403(Non-Statin MAD)
干预措施: SGB-3403 (Drug)
placebo(Non-Statin MAD)
干预措施: Placebo (Other)
SGB-3403 and atorvastatin(statin MAD)
干预措施: SGB-3403 (Drug)
SGB-3403 and atorvastatin(statin MAD)
干预措施: Atorvastatin (Other)
placebo and atorvastatin(statin MAD)
干预措施: Atorvastatin (Other)
placebo and atorvastatin(statin MAD)
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with abnormal laboratory tests results
时间窗: 169 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Number of participants with adverse events (AEs)
时间窗: 169 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
次要结局
- LDL-C change from baseline(265 days)
- Maximum observed plasma concentration (Cmax)(48 hours)
- Area under the concentration-time curve (AUC)(48 hours)
- PCSK9 change from baseline(265 days)