A Phase 1 Study Testing Single Doses of CITY-FXI by Injection to Evaluate Safety and Effects in Healthy Adults and Adults with Factor V Leiden or Prothrombin G20210A Mutation

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CITY-FXI, a drug targeting Factor XI, in healthy adults and adults with Factor V Leiden FVL or prothrombin G20210A mutation. This first-in-human, randomized, double-blind, placebo-controlled study aims to better understand how CITY-FXI works in these populations and its potential effects. The trial is sponsored by City Therapeutics and includes participants aged 18 to 60 years. The study consists of two parts Part A involves single ascending doses of CITY-FXI or placebo given by subcutaneous injection to healthy adults, and Part B includes similar dosing in adults diagnosed with FVL or prothrombin G20210A mutation. Women of childbearing potential in Part B must use highly effective contraception. The doses will be increased in a controlled manner to assess safety and drug behavior. Participants will be monitored for adverse events throughout the study, up to 360 days after dosing. Researchers will measure drug levels in the blood and urine shortly after dosing, and track changes in blood clotting factors and activity over time. Study visits will include physical exams, laboratory tests, and safety assessments to evaluate treatment effects and participant well-being over the follow-up period.

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