NCT05661916已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneously Administered ALN-TTRSC04 in Healthy Subjects
Alnylam Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年1月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending doses of ALN-TTRSC04.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Body mass index (BMI) ≥18.0 kg/m^2 and ≤30 kg/m^2 assessed at Screening.
排除标准
- •Has an estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m^2 at screening.
- •Has alanine aminotransferase (ALT), aspartate aminotransferase (AST) or direct bilirubin above the upper limit of normal (ULN).
研究组 & 干预措施
ALN-TTRSC04
Experimental
Participants will be administered a single dose of ALN-TTRSC04.
干预措施: ALN-TTRSC04 (Drug)
Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Adverse Events
时间窗: Up to 20 months
次要结局
- Area Under the Concentration-time Curve (AUC) of ALN-TTRSC04(Day 1 up to Day 4)
- Fraction of ALN-TTRSC04 Excreted in the Urine (fe)(Up to Day 2)
- Maximum Observed Plasma Concentration (Cmax) of ALN-TTRSC04(Day 1 up to Day 4)
- Time to Maximum Observed Plasma Concentration (Tmax) of ALN-TTRSC04(Day 1 up to Day 4)
- Change from Baseline in Serum Transthyretin (TTR) Levels Over Time(Up to 18 months)
研究者
研究点 (2)
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