NCT07295717招募中1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-4285 in Adult Healthy Volunteers
Alnylam Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年12月12日最近更新:
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
- 76
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to:
- evaluate the safety and tolerability of single ascending doses of ALN-4285 in healthy volunteers
- characterize the single-dose pharmacokinetics (PK) of ALN-4285
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
- •Has a body mass index (BMI) of ≥18.0 kg/m^2 and ≤30 kg/m^2
- •Has 12-lead ECG within normal limits or with no clinically significant abnormalities in the opinion of the Investigator
排除标准
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
- •Has total bilirubin >ULN
- •Has systolic blood pressure >140 mmHg and/or a diastolic blood pressure >90 mmHg
- •Has an estimated glomerular filtration (eGFR) of <90 mL/min/1.73m^2 at screening
- •Has received an investigational agent within the last 30 days or 5 half-lives
研究组 & 干预措施
ALN-4285
Experimental
Participants will be administered ALN-4285 subcutaneously (SC)
干预措施: ALN-4285 (Drug)
Placebo
Placebo Comparator
Participants will be administered placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs)
时间窗: Up to Week 24
次要结局
- Concentration of ALN-4285 in Plasma(Up to Day 3)
研究者
研究点 (2)
Loading locations...
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