NCT07535606招募中1 期
A Phase 1, Randomized, Double-Masked, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-4915 in Adult Healthy Volunteers
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年3月2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
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 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 ALN-4915.
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
- •Is willing and able to complete all study assessments
排除标准
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
- •Has total bilirubin >ULN
- •Has no history of invasive infection by an encapsulated organism
- •Has no known complement or immunologic deficiency
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
干预措施: Placebo (Drug)
ALN-4915
Experimental
Participants will be administered a single dose of ALN-4195.
干预措施: ALN-4915 (Drug)
结局指标
主要结局
Frequency of Adverse Events
时间窗: Serious adverse events (SAEs) after signing of ICF up to Month 12; nonserious AEs after first dose of study drug up to Month 12
次要结局
- Change from Baseline Inflammatory Markers in Plasma(Baseline up to Month 9)
- Concentration of ALN-4915 in Plasma(Predose up to Day 3)
- Concentration of ALN-4915 in Urine(Predose up to Day 1)
研究者
研究点 (1)
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