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A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults, Adults With FV Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism

2026年9月23日 更新者：City Therapeutics

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

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).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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)

研究类型

介入性

注册 (估计的)

182

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：CITY-FXI 在健康成人中的研究（A部分）
药品：CITY-FXI

siRNA (subcutaneous injection)
安慰剂比较：在健康成人中（A部分）
药品：Placebo

Saline (subcutaneous injection)
实验性的：成人因子V莱顿或凝血酶原G20210A突变CITY-FXI研究（B部分）
药品：CITY-FXI

siRNA (subcutaneous injection)
安慰剂比较：在患有因子V Leiden或凝血酶原G20210A突变的成人中（B部分）
药品：Placebo

Saline (subcutaneous injection)
实验性的：CITY-FXI in Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)
药品：CITY-FXI

siRNA (subcutaneous injection)
安慰剂比较：In Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)
药品：Placebo

Saline (subcutaneous injection)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)
大体时间：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
Through study completion, up to Day 360

次要结果测量

结果测量
措施说明
大体时间
Maximum plasma concentration (Cmax)
大体时间：Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with 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
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
大体时间：Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with 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
Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)
Amount excreted in urine (Ae) of CITY-FXI
大体时间：Day 1 to Day 3 (Parts A and B)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation
Day 1 to Day 3 (Parts A and B)
Change from baseline in levels of plasma Factor XI (FXI)
大体时间：Up to Day 360

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with 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
Up to Day 360
Change from baseline of Factor XI (FXI) activity
大体时间：Up to Day 360

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with 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
Up to Day 360
Change from baseline in activated partial thromboplastin time (aPTT)
大体时间：Up to Day 360

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with 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
Up to Day 360

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

City Therapeutics

调查人员

  • 研究主任：Medical Director、City Therapeutics

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月22日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2026年1月9日

首先提交符合 QC 标准的

2026年2月18日

首次发布 (实际的)

2026年2月24日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FXI-1101
  • C24027 (其他标识符：Richmond Pharmacology)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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