Randomized Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

Inclusion Criteria:

- Male or female subjects, age 18 to 75 years admitted to hospital with a clinical
diagnosis of acute PE categorized as low risk or intermediate-risk or submassive PE
and for whom catheter-based therapy is not planned;

- Subjects must have a CTA scan confirming the PE diagnosis and with at least one
measurable index lesion in a segmental or larger pulmonary artery prior to
randomization;

- Subjects should be in otherwise satisfactory health in the opinion of the
Investigator;

- Subjects must be able to provide written informed consent.

Exclusion Criteria:

- Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically
unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of
< 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since
presentation;

- Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;

- Subjects with PE lesions only in the sub-segmental or smaller arteries;

- Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or
receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in
therapeutic doses prior to randomization;

- Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or
aneurysm, head trauma, or evidence of active bleeding;

- Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such
as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;

- Subjects who within 21 days prior to randomization have had gastrointestinal or
genitourinary bleeding;

- Subjects who within 14 days prior to randomization have had major surgery or a lumbar
puncture (or epidural steroid injection);

- Subjects with diagnosed active liver disease or with elevation of liver
enzymes/bilirubin.