A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Incidence of dose limiting or intolerable treatment related adverse events (AEs).
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LDL-C must be greater or equal to 130 mg/dl
- •BMI must be between 18.5 and 40 kg/m2
排除标准
- •History of cardiovascular or cerebrovascular event during the past year.
- •Poorly controlled type 1 or type 2 diabetes mellitus
- •Subjects who have taken lipid lowering therapies within the last 3 months of screening.
结局指标
主要结局
Incidence of dose limiting or intolerable treatment related adverse events (AEs).
时间窗: Every Scheduled Visit
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
时间窗: Every Scheduled Visit
Incidence of abnormal and clinically relevant safety laboratories.
时间窗: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
时间窗: Every Scheduled Visit
Incidence of anti-drug-antibodies.
时间窗: Baseline and Day 15 and monthly thereafter
次要结局
- PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316.(Day 1 and every scheduled visit thereafter)
- Absolute and percentage change in LDL C from baseline.(Every scheduled visit except Day 1)
- Proportion of subjects who achieve a target LDL C of <100 mg/mL.(Every scheduled visit except Day 1)
- Proportion of subjects who achieve a target LDL C of <70 mg/dL.(Every scheduled visit except Day 1)
- Proportion of subjects achieving 50% decrease in LDL C from baseline.(Every scheduled visit except Day 1)