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CITY-FXI

Phase 1

Factor V Leiden | Small molecule | Cardiovascular |City Therapeutics, Inc.|Trials Updated: Sep 25, 2026

CITY-FXI development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment182

FDA Designations

No designations recorded

CITY-FXI clinical trials

CITY-FXI · 1 trial · 3 indications

Phase 1 1
NCT07430397A 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 ThromboembolismFactor V Leiden
RECRUITING182 Analytics
PHASE1RECRUITING
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
Factor V Leiden
NCT07430397182
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Maximum plasma concentration (Cmax)
Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)
Area under plasma concentration time curve (AUC) of CITY-FXI
Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)
Amount excreted in urine (Ae) of CITY-FXI
Day 1 to Day 3 (Parts A and B)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CITY-FXI in Healthy Adults (Part A)EXPERIMENTAL -
In Healthy Adults (Part A)PLACEBO_COMPARATOR -
CITY-FXI in Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)EXPERIMENTAL -
In Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)PLACEBO_COMPARATOR -
CITY-FXI in Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)EXPERIMENTAL -
In Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CITY-FXIDRUGsiRNA (subcutaneous injection)
PlaceboDRUGSaline (subcutaneous injection)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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/...

Countries:United Kingdom
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