A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency

The objective is to administer a single dose of sutacimig and to evaluate safety, pharmacokinetics, and pharmacodynamics. Two cohorts may be evaluated. Cohort A is defined by participants with a FVII(a) level of < 10%. Cohort B is defined by participants with a FVII(a) level of ≥10%.

Inclusion criteria

• Age 18 to 60 years, inclusive, at the time of signing informed consent.
• Diagnosis of FVIID defined by Factor VII:C activity < 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.
• Severe bleeding history characterized by history of a major bleeding event and/or receipt of recombinant activated FVII or fresh frozen plasma as treatment for bleeding or a severe clinical bleeding history as defined by the Investigator.
• Has the ability to provide informed consent to participate in the trial.

Exclusion criteria

• Presence of known inhibitors to FVII or FVIIa
• History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
• History of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated superficial vein thrombosis.
• Known thrombophilia risk by the following criteria: Homozygous Factor V Leiden (FVL), compound heterozygous FVL/Prothrombin gene mutation, antithrombin <50%, congenital protein C, and protein S deficiency with levels <50%.
• Clinically significant comorbidity that may interfere with study participation.
• Use of concomitant therapy not permitted during the study (i.e., other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment [e.g., for oral bleeds])
• Female participants who are pregnant or breastfeeding.