NCT02053454已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Japanese Healthy Volunteers
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年1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
- 12
- 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 evaluate the safety, tolerability and pharmacokinetics (PK) of patisiran (ALN-TTR02) in Japanese 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese adult males and females aged 20 to 65 years, inclusive (The subject was born in Japan and has lived outside of Japan for <10 years, and subject's biological parents and grandparents are fully Japanese and were born in Japan);
- •Subjects who are healthy as determined by clinical assessments;
- •Females subjects must be of non-childbearing potential;
- •Males with partners of child-bearing potential, must agree to use appropriate contraception.
排除标准
- •Subjects with a history of serious mental illness;
- •Subjects who have a clinically relevant medical or surgical history;
- •Subjects with a positive screen for alcohol or drugs of abuse;
- •Subjects with safety laboratory test results deemed clinically significant;
- •Subjects with known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection;
- •Subjects who have received an investigational agent within the 3 months prior to study entry.
研究组 & 干预措施
patisiran (ALN-TTR02)
Active Comparator
干预措施: patisiran (ALN-TTR02) (Drug)
Sterile Normal Saline (0.9% NaCl)
Active 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
- Pharmacodynamics (PD) of ALN-TTR02 (serum concentrations of Transthyretin, Vitamin A, and Retinol Binding Protein)(Up to 90 days)
- Time of observed maximum concentration (tmax) of ALN-TTR02(Up to 90 days)
- Area under the plasma concentration versus time curve (AUC) of ALN-TTR02(Up to 90 days)
- Systemic clearance (CL) of ALN-TTR02(Up to 90 days)
- Renal clearance (CLR) of ALN-TTR02(Up to 90 days)
- Observed maximum concentration (Cmax) of ALN-TTR02(Up to 90 days)
- Volume of distribution (V) of ALN-TTR02(Up to 90 days)
- Terminal elimination half-life (t1/2) of ALN-TTR02(Up to 90 days)
研究者
研究点 (1)
Loading locations...
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