Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects (SAD)
- •Healthy Subjects (MAD) with untreated elevated cholesterol
- •Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
- •Women who are not of childbearing potential and men, ages 18 to 45
排除标准
- •Any significant acute or chronic medical illness
- •History of liver or renal disorders
- •Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration
研究组 & 干预措施
Arm 1 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 2 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 3 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 4 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 5 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 6 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 7 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 8 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 9 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 10 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 11 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 12 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 13 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 14 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
Arm 15 - BMS-844421
干预措施: BMS-844421 (Drug)
Arm 16 - 0.9% sodium chloride injection solution
干预措施: 0.9% sodium chloride injection solution (Drug)
结局指标
主要结局
To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations
时间窗: At the conclusion of the MAD part of the study
次要结局
- Assess the effects of multiple doses of BMS-844421on lipid components(All outcomes will be assessed at the conclusion of the MAD part of the study)
- Assess the absolute bioavailability of single BMS-844421 SC doses(All outcomes will be assessed at the conclusion of the MAD part of the study)
- Assess single and multiple dose pharmacokinetics of BMS-844421(All outcomes will be assessed at the conclusion of the MAD part of the study)