NCT07430397招募中1 期
A Phase 1, Randomised, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-FXI, a FXI Targeting siRNA, Administered Subcutaneously in Healthy Adults and Adults With Factor V Leiden or Prothrombin G20210A Mutation
City Therapeutics1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年1月22日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a first-in-human (FIH), single-center, randomised, double-blind, placebo-controlled, single ascending dose (SAD) study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation.
详细描述
The study will be conducted in two parts:
- Part A: Single Ascending Dose in Healthy Adults
- Part B: Single Ascending Dose in Adults with Factor V Leiden (FVL) or Prothrombin G20210A Mutation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (Part A only)
- •Male and female participants aged 18 to 60 (Part B only)
- •Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive) and a minimum weight of 50 kg
- •Ability and willingness to comply fully with all study procedures and lifestyle considerations
- •Confirmed diagnosis of FVL or prothrombin G20210A mutation via genetic testing (Part B only)
- •Women of childbearing potential (WOCBP) must agree to use acceptable highly effective contraceptive methods (Part B only)
排除标准
- •Any clinically significant systemic disease or disorder, including but not limited to cardiovascular, hepatic, or oncological conditions
- •History or evidence of any bleeding disorders
- •History of clinically significant spontaneous bleeding
- •Prior treatment with an investigational agent
- •Confirmed diagnosis of homozygous mutations, or combined thrombophilic defects of (Part B only)
研究组 & 干预措施
CITY-FXI in Healthy Adults (Part A)
Experimental
干预措施: CITY-FXI (Drug)
In Healthy Adults (Part A)
Placebo Comparator
干预措施: Placebo (Drug)
CITY-FXI in Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)
Experimental
干预措施: CITY-FXI (Drug)
In Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)
时间窗: Through study completion, up to Day 360
To evaluate the safety and tolerability of a single dose of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation
次要结局
- Maximum plasma concentration (Cmax)(Day -1 to Day 3)
- Area under plasma concentration time curve (AUC) of CITY-FXI(Day -1 to Day 3)
- Amount excreted in urine (Ae) of CITY-FXI(Day -1 to Day 3)
- Change from baseline in levels of plasma Factor XI (FXI)(Up to Day 360)
- Change from baseline of Factor XI (FXI) activity(Up to Day 360)
- Change from baseline in activated partial thromboplastin time (aPTT)(Up to Day 360)
研究者
研究点 (1)
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