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
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Factor V Leiden, Prothrombin G20210A
In brief
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.
Key facts
- Study ID
- NCT07430397
- Run by
- City Therapeutics
- People needed
- 128
- Starts
- 2026-01-22
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Richmond Pharmacology — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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