NCT01437059已完成1 期
A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation.
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol (LDL-C).
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
- Single (Participant)
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
- •Elevated LDL-C of >3.0 mmol/L and <5.7 mmol/L
- •Fasting triglyceride concentration ≤2.8 mmol/L
- •Body weight >60.0 kg; body mass index (BMI) between 19.00 kg/m2 and <35.00 kg/m2
- •Adequate blood counts, liver and renal function
- •May not received any lipid lowering drug/agent within the 30 days prior to the screening
- •Non-smokers for at least 3 months
- •Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control
- •Males agree to use appropriate contraception
- •Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent
排除标准
- •Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
- •Multiple drug allergies or know sensitivity to oligonucleotide
- •History of drug abuse and/or alcohol abuse
- •Receiving an investigational agent within 3 months prior to study drug administration
- •Subjects with safety laboratory test results deemed clinical significant by the Investigator;
- •Received prescription drugs within 4 weeks of first dosing
- •Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
- •Received megadose vitamin therapy or dietary supplements within 4 weeks prior to screening
- •Subjects who have used prescription drugs within 4 weeks of first dosing
- •Considered unfit for the study by the Principal Investigator
- •Employee or family member of the sponsor or the clinical study site personnel
研究组 & 干预措施
ALN-PCS02
Active Comparator
干预措施: ALN-PCS02 (Drug)
Sterile Normal Saline (0.9% NaCl)
Placebo Comparator
干预措施: Sterile Normal Saline (0.9% NaCl) (Drug)
结局指标
主要结局
The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation.
时间窗: Up to 28 days
次要结局
- Pharmacokinetics (PK) of ALN-PCS02 (Cmax, tmax, t1/2, AUC0-last, CL).(Up to 180 days)
- Effect of ALN-PCS02 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to pretreatment/Baseline PCSK9 Level).(Up to 28 days)
- Effect of ALN-PCS02 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to pretreatment/Baseline LDL-c Level).(Up to 28 days)
研究者
研究点 (1)
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