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, Adults With Factor V Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism
City Therapeutics1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2026年1月22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
- 182
- 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, randomized, double-blind, placebo-controlled, single ascending and multiple dose study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults, adults with Factor V Leiden (FVL) or prothrombin G20210A mutation, and adults with a history of provoked venous thromboembolism (VTE).
详细描述
The study will be conducted in three 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
- Part C: Multiple Doses in Adults with FVL or Prothrombin G20210A Mutation and/or a History of Provoked Venous Thromboembolism (VTE)
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 65 Years（Adult, Older 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 (inclusive, for Part A only)
- •Male and female participants aged 18 to 60 (inclusive, for Part B only), and aged 18 to 65 years (inclusive, for Part C only)
- •Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive, for Part B only) and 18 and 35 kg/m2 (inclusive, for Part C only) and a minimum weight of 50 kg (Parts A, B, and C)
- •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 (Parts B and C only)
- •History of provoked venous thromboembolism (VTE) within the last 10 years and/or confirmed diagnosis of heterozygosity for FVL and prothrombin G20210A mutation via genetic testing (Part C 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 (e.g., FVL with prothrombin G20210A mutation) (Parts B and C only)
研究组 & 干预措施
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)
CITY-FXI in Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)
Experimental
干预措施: CITY-FXI (Drug)
In Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)
Placebo Comparator
干预措施: Placebo (Drug)
CITY-FXI in Healthy Adults (Part A)
Experimental
干预措施: CITY-FXI (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, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
次要结局
- 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)
- Maximum plasma concentration (Cmax)(Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C))
- Area under plasma concentration time curve (AUC) of CITY-FXI(Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C))
- Amount excreted in urine (Ae) of CITY-FXI(Day 1 to Day 3 (Parts A and B))
- 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)
研究者
研究点 (1)
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