NCT01559077已完成1 期
A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Healthy Volunteers
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2012年3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
- 17
- 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-TTR02 in healthy volunteer subjects.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index must be between 18.0 kg/m2 and ≤ 31.5 kg/m2;
- •Non-smokers for at least 3 months preceding screening;
- •Females subjects must be of non-childbearing potential e.g., post-menopausal or pre-menopausal with surgical sterilization;
- •Males agree to use appropriate contraception;
- •Medical history must be verified by either a personal physician or medical practitioner as appropriate;
- •Willing to give written informed consent and are willing to comply with the study requirements.
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;
- •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-TTR02
Active Comparator
干预措施: ALN-TTR02 (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-TTR02 (Cmax, tmax, t1/2, AUC0-last, CL).(Up to 180 days)
- Effect of ALN-TTR02 on transthyretin (TTR), vitamin A, and retinol binding protein (RBP) (Determination of % Lowering of TTR, vitamin A and RBP to pretreatment/Baseline Levels)(Up to 56 days)
研究者
研究点 (1)
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