Actively Recruiting
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
Led by City Therapeutics · Updated on 2026-02-24
128
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and women of non-childbearing potential aged 18 to 45 years (Part A only)
- Male and female participants aged 18 to 60 years (Part B only)
- Body Mass Index (BMI) between 18 and 25 kg/m2 and minimum weight of 50 kg
- Ability and willingness to comply fully with all study procedures and lifestyle requirements
- Confirmed diagnosis of Factor V Leiden or Prothrombin G20210A mutation via genetic testing (Part B only)
- Women of childbearing potential must agree to use highly effective contraceptive methods (Part B only)
You will not qualify if you...
- Any clinically significant systemic disease or disorder, including cardiovascular, liver, or cancer 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 (Part B only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Richmond Pharmacology
London, United Kingdom, SE1 1YR
Actively Recruiting
Research Team
C
City Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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