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

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.

NCT Number	NCT07430397
Lead Sponsor	City Therapeutics
Conditions	Factor V Leiden, Prothrombin G20210A
Enrollment	128 participants
Start Date	2026-01-22
Primary Completion	2027-08 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-24