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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

NCT07430397 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

  • Factor V Leiden
  • Prothrombin G20210A

Interventions

DRUG

CITY-FXI

siRNA (subcutaneous injection)

DRUG

Placebo

Saline (subcutaneous injection)

Sponsors & Collaborators

  • City Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2027-08-31
Completion
2027-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430397 on ClinicalTrials.gov