A Phase 1B Randomized Double-Blind Placebo-Controlled Multi-Center Single Ascending Dose Study to Assess the Safety Efficacy Pharmacokinetics and Pharmacodynamics of DS-1040B When Added to Standard of Care Anticoagulation Therapy in Subjects with
Brief description of study
This study is to evaluate the safety and tolerability using bleeding as the primary endpoint. Secondarily, this study will serve as a proof-of concept by evaluating the effect that DS-1040b (the investigative drug) administration has on total thrombus volume reduction from baseline to the end of infusion, assessed by contrast enhanced computed tomography scan (CT angiography or CTA). This study will also evaluate the pharmacokinetic/pharmacodynamic (PK/PD) and biomarker activity of DS-1040b in subjects with acute PE and the correlation with imaging.
Clinical Study Identifier: s17-00111
ClinicalTrials.gov Identifier: NCTs17-00111
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