Overview
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.
Description
The study will be conducted in two parts:
- Part A: Single Ascending Dose in Healthy Adults
- Part B: Single Ascending Dose in Adults with Factor V Leiden (FVL) or Prothrombin G20210A Mutation
Eligibility
Inclusion Criteria:
- Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (Part A only)
- Male and female participants aged 18 to 60 (Part B only)
- Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive) and a minimum weight of 50 kg
- 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 (Part B 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 of (Part B only)
