NCT06669234进行中（未招募）1 期
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ALN-F1202, an siRNA Against Factor XII, in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Severity of TEAEs
研究概览
简要总结
This clinical research trial will evaluate the safety and tolerability of an experimental drug, ALN-F1202, in healthy participants.
The purpose of this trial is to learn about how safe and tolerable the experimental drug is. The trial is looking at several other research questions, including:
- What side effects may happen from taking the experimental drug?
- How much experimental drug is in the blood at different times?
- Whether the body makes antibodies against the experimental drug (which could make the drug less effective or could lead to side effects).
- What is the best dose of the experimental drug?
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
- •Has a body mass index between 18 and 32 kg/m2, inclusive
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
- •Is in good health based on laboratory safety testing obtained at the screening visit, as described in the protocol
- •Normal aPTT, normal PT, and normal platelet counts at screening period and at day -1 as defined by the local laboratory
- •Hemoglobin values at screening period and at day -1 as described in the protocol
排除标准
- •History of any major surgical procedure or clinically significant physical trauma, in the opinion of the investigator, that may pose a risk to the participant by study participation
- •Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening
- •History of clinically significant bleeding, requiring hospitalization or blood products, that in the opinion of the investigator may pose a risk to the participant by study participation
- •History of bleeding diathesis as described in the protocol
- •Members of the clinical site study team and/or his/her immediate family, unless prior approval granted by the sponsor
- •Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- •NOTE: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo
Experimental
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
ALN-F1202
Experimental
Randomized as described in the protocol Escalating Cohorts including Optional Cohorts
干预措施: ALN-F1202 (Drug)
结局指标
主要结局
Severity of TEAEs
时间窗: Up to 190 Days
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 190 Days
次要结局
- Change in activated Partial Thromboplastin Time (aPTT)(Baseline up to 190 Days)
- Change in Prothrombin Time (PT)(Baseline up to 190 Days)
- Concentration of combined ALN-F1202 and metabolites in plasma(Up to 190 Days)
- Extent of urinary excretion of combined ALN-F1202 and metabolites(Within 24 hours of treatment)
研究者
研究点 (2)
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