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.
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
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