A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacody… (NCT07430397) | Clinical Trial Compass
RecruitingPhase 1
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
United Kingdom128 participantsStarted 2026-01-22
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)
Timeframe: Through study completion, up to Day 360