drugset / Trial / NCT07430397

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

NCT07430397 ↗

Phase 1 Recruiting 128 enrolled City Therapeutics
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2026-01-22
Primary completion
2027-08
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CITY-FXI Small interfering RNA (siRNA) — Subcutaneous