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RecruitingPhase 1NCT07430397

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

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

Sponsor

City Therapeutics

Enrollment

128 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Factor V LeidenProthrombin G20210A

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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)

Exclusion Criteria5

  • 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)

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Interventions

DRUGCITY-FXI

siRNA (subcutaneous injection)

DRUGPlacebo

Saline (subcutaneous injection)

Locations(1)

Richmond Pharmacology

London, United Kingdom

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NCT07430397