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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Oct 2026

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At a glance

  • Drugs CITY FXI (Primary)
  • Indications Thromboembolism
  • Focus Adverse reactions; First in man
  • Sponsors City Therapeutics

Most Recent Events

  • 25 Sep 2026 Protocol amended to change number of arms form 4 to 6, CITY-FXI in Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C) and Placebo Comparator: In Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C) arms added. Patient number increased.
  • 25 Sep 2026 Planned number of patients changed from 128 to 182.
  • 08 Jun 2026 According to City Therapeutics media release, Company plans to initiate a Phase 1 study by year-end 2026.

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