3 results
to investigate the safety and efficacy of idarucizumab in reversing the anticoagulation effect of dabigatran, in patients who have uncontrolled bleeding or require emergency surgery or invasive procedures.
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…
Part A (Healthy volunteers)Primary:• To assess safety and tolerability of multiple doses of NX210cSecondary• To evaluate the pharmacokinetic (PK) profile of NX210c in plasma after multiple doses. • To evaluate the exposure of NX210c in cerebrospinal…