NCT02314442已完成1 期
A Phase 1, Randomized, Single Blind, Placebo Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN PCSSC in Subjects With Elevated Low Density Lipoprotein Cholesterol
Alnylam Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年12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
- 70
- 试验地点
- 2
- 主要终点
- The safety of ALN-PCSSC evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adequate complete blood counts, liver and renal function
- •Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization
- •Male subjects agree to use appropriate contraception
- •Willing to provide written informed consent and willing to comply with study requirements.
- •Non-smokers and non-nicotine users for at least 90 days before screening
- •On stable statin co-medication [for designated multiple dose cohorts only]
排除标准
- •Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
- •Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
- •History of multiple drug allergies or intolerance to subcutaneous injection
- •Received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)
研究组 & 干预措施
ALN-PCSSC
Active Comparator
干预措施: ALN-PCSSC (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 safety of ALN-PCSSC evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation
时间窗: Part 1 (SAD phase): up to 180 days post dose; Part 2 (MD) phase: up to 180 days post final dose
次要结局
- The pharmacokinetics (PK) of ALN-PCSSC (Cmax, tmax, AUC, t1/2)(Part 1 (SAD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 42, 56 days post-dose; Part 2 (MD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 29, 35, 42, 56, 84 days post-dose)
- The effect of ALN-PCSSC on plasma levels of PCSK9(Through the sooner of final follow up visit or 180 days post final dose)
- The effect of ALN-PCSSC on serum levels of LDL-C(Through the sooner of final follow up visit or 180 days post final dose)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy SubjectsTransthyretin-mediated Amyloidosis (ATTR Amyloidosis)NCT02797847Alnylam Pharmaceuticals80
已完成
1 期
Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)Elevated LDL-Cholesterol (LDL-C)NCT01437059Alnylam Pharmaceuticals32
已完成
1 期
Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer SubjectsTTR-mediated AmyloidosisNCT01559077Alnylam Pharmaceuticals17
已完成
1 期
Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) AmyloidosisTransthyretin Mediated Amyloidosis (ATTR)NCT01148953Alnylam Pharmaceuticals32
进行中（未招募）
1 期
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic SubjectsHypertriglyceridemiaNCT06471543Ikaria Bioscience Pty Ltd108