NCT07430397 A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults, Adults With FV Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism
| NCT ID | NCT07430397 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | City Therapeutics |
| Condition | Factor V Leiden |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 182 participants in total. It began in 2026-01-22 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending and multiple dose study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults, adults with Factor V Leiden (FVL) or prothrombin G20210A mutation, and adults with a history of provoked venous thromboembolism (VTE).
Eligibility Criteria
Inclusion Criteria: * Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (inclusive, for Part A only) * Male and female participants aged 18 to 60 (inclusive, for Part B only), and aged 18 to 65 years (inclusive, for Part C only) * Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive, for Parts A and B only) and 18 and 35 kg/m2 (inclusive, for Part C only) and a minimum weight of 50 kg (Parts A, B, and C) * 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 (Parts B and C only) * History of provoked venous thromboembolism (VTE) within the last 10 years and/or confirmed diagnosis of heterozygosity for FVL or prothrombin G20210A mutation via genetic testing (Part C 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 (e.g., FVL with prothrombin G20210A mutation) (Parts B and C only)
Contact & Investigator
Medical Director
STUDY DIRECTOR
City Therapeutics
Frequently Asked Questions
Who can join the NCT07430397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Factor V Leiden. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07430397 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07430397 currently recruiting?
Yes, NCT07430397 is actively recruiting participants. Contact the research team at clinicaltrials@citytx.com for enrollment information.
Where is the NCT07430397 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07430397 clinical trial?
NCT07430397 is sponsored by City Therapeutics. The principal investigator is Medical Director at City Therapeutics. The trial plans to enroll 182 participants.