NCT01814839已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC in Healthy Volunteers
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2013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
- 85
- 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 ALN-TTRSC (revusiran) 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) must be ≥ 16.5 kg/m2 and ≤ 35.0 kg/m2;
- •Female subjects must be of non-childbearing potential; e.g., postmenopausal or pre-menopausal with surgical sterilization;
- •Male subjects agree to use appropriate contraception;
- •Adequate blood counts, liver and renal function;
- •Non-smokers for at least 3 months;
- •Willing to give written informed consent and are willing to comply with the study requirements;
- •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 (cohorts 19 and 20).
排除标准
- •Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
- •Subjects with a history of multiple drug allergies or intolerance to SC injection;
- •History of drug abuse and/or alcohol abuse;
- •Receiving an investigational agent within 3 months prior to study drug administration;
- •Considered unfit for the study by the Principal Investigator.
研究组 & 干预措施
ALN-TTRSC (revusiran)
Active Comparator
干预措施: ALN-TTRSC (revusiran) (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 63 days
次要结局
- Pharmacokinetics (PK) of ALN-TTRSC (revusiran) (Cmax, tmax, t1/2, AUC0-last, CL).(Up to 90 days)
- Effect of ALN-TTRSC (revusiran) on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels).(Up to 90 days)
- Effect of ALN-TTRSC (revusiran) on retinol binding protein (RBP) (Determination of % Lowering of RBP to pretreatment/Baseline Levels).(Up to 90 days)
- Effect of ALN-TTRSC (revusiran) on vitamin A (Determination of % Lowering of vitamin A to pretreatment/Baseline Levels).(Up to 90 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase 1 Dose Escalation Study of VX-973 in Healthy AdultsPainNCT05866055Vertex Pharmaceuticals Incorporated30
已完成
1 期
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy ParticipantsAcute PainNCT05347394Vertex Pharmaceuticals Incorporated100
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy VolunteersHealthy VolunteersNCT06625541AnnJi Pharmaceutical Co., Ltd.57
已完成
1 期
A Single and Multiple-Dose Study of SB1578Healthy VolunteerNCT01235871S*BIO40
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy VolunteersHealthyNCT02480296MyoKardia, Inc.60