NCT02797847已完成1 期
A Phase 1, Randomized, Single-Blind, Placebo Controlled, Single-Ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-TTRSC02 in Healthy Subjects
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年6月7日最近更新:
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
- 80
- 试验地点
- 1
- 主要终点
- Safety of ALN-TTRSC02, evaluated by the proportion of subjects experiencing adverse events (AEs)
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC02 in healthy 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, age 18 to 65 years, inclusive.
- •Body mass index (BMI) ≥18.0 kg/m2 and ≤30 kg/m2 assessed at Screening.
- •No clinically significant health concerns, as determined by medical history and physical examination, in the opinion of the Investigator.
- •Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception, willing and able to comply with the study requirements and to provide written informed consent.
- •For Japanese cohorts, subjects of Japanese descent are defined as people carrying a Japanese passport, descendants of 4 Japanese grandparents, and have not been outside Japan for more than 5 years.
排除标准
- •Clinically relevant history or presence of respiratory, gastrointestinal, renal, cardiovascular, hepatic, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, and other inflammatory diseases, or dermatological or connective tissue diseases or disorders.
- •Active serious mental illness or psychiatric disorder.
- •Clinically significant ECG abnormalities. Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant.
- •Known history of allergic reaction to an oligonucleotide or GalNAc.
- •History of intolerance to subcutaneous injection.
研究组 & 干预措施
ALN-TTRSC02
Active Comparator
干预措施: ALN-TTRSC02 (Drug)
Sterile normal saline 0.9% for SC administration
Placebo Comparator
干预措施: Sterile Normal Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Safety of ALN-TTRSC02, evaluated by the proportion of subjects experiencing adverse events (AEs)
时间窗: Day 1 through to Day 314
次要结局
- Profile of pharmacokinetics (PK) of ALN-TTRSC02(Day 1 through to Day 314)
- Effect of ALN-TTRSC02 on serum Vitamin A levels as measured by reduction from baseline in serum Vitamin A(Screening through to Day 314)
- Effect of ALN-TTRSC02 on serum TTR levels as measured by reduction from baseline in serum TTR(Day 1 through to Day 314)
研究者
研究点 (1)
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