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Background  Coagulation factor  XI  ( FXI ) contributes to the development of thrombosis but appears to play only a minor role in hemostasis and is therefore an attractive anticoagulant drug target.    Objectives  To evaluate the safety, pharmacodynamic, and pharmacokinetic properties of  BAY  1213790, a fully human immunoglobulin (Ig) G1 antibody targeting activated coagulation  FXI  ( FXI a), in healthy men.    Methods  In this phase 1, single‐blind, parallel‐group, placebo‐controlled, dose‐escalation study, 83 healthy Caucasian men were randomized 4:1 to receive a single 60‐minute intravenous infusion of  BAY  1213790 (0.015‐10 mg/kg) or placebo. Adverse events, pharmacodynamic parameters (including activated partial thromboplastin time [ aPTT ]) and pharmacokinetic parameters were determined. Volunteers were followed up for 150 days.    Results   BAY  1213790 demonstrated favorable safety and tolerability; there were no observed cases of bleeding or clinically relevant antidrug antibody formation. One volunteer (1.2%) experienced an infusion reaction. Following intravenous administration of  BAY  1213790, dose‐dependent increases in  aPTT  (maximal mean increase relative to baseline: 1.85 [conventional method] and 2.17 [kaolin‐triggered method]) and rotational thromboelastometry whole blood clotting time were observed, as well as dose‐dependent reductions in  FXI  activity. Bleeding times did not increase following administration of  BAY  1213790 and were similar for all dose cohorts, including placebo. Measurable and dose‐dependent increases in systemic exposure were detected for all doses of  BAY  1213790 of 0.06 mg/kg or higher.    Conclusions  Based on these safety, pharmacodynamic, and pharmacokinetic results, further evaluation of  BAY  1213790 in patients with, or at risk of, thrombosis is warranted.

BAY 1213790, a fully human IgG1 antibody targeting coagulation factor XI a: First evaluation of safety, pharmacodynamics, and pharmacokinetics