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Clinical Trials in the UK / NCT07430397
Recruiting Phase 1

A Single Ascending Dose 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

NCT07430397 · tracked via the Priya Life Science UK tracker
Sponsor
City Therapeutics
Phase
Phase 1
Started
2026-01-22
Last updated
2026-09-25

Condition(s) studied

Factor V LeidenProthrombin G20210AVenous Thromboembolism (VTE)

Investigational drug(s) / intervention(s)

CITY-FXIPlacebo

CITY-FXI: siRNA (subcutaneous injection)

Placebo: Saline (subcutaneous injection)

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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 Part 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 and 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)

Primary outcome measure(s)

  • Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) — Through study completion, up to Day 360
    To evaluate the safety and tolerability of a single dose of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE

Trial sites (1)

FacilityCityRegionStatus
Richmond Pharmacology London United Kingdom Recruiting

Other trials for the same condition

Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07430397 on ClinicalTrials.gov ↗ ← All trials in the UK