DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)

Evaluation of Safety and Thrombolytic Effect of Ascending Doses of DS-9231 (TS23) in Subjects With Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)

The primary objective of this study is to evaluate safety and initial effectiveness of DS-9231 when taken together with current standard of care. Evaluation will be done with low, medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute pulmonary embolism.

Inclusion Criteria:

• Had protocol-defined pulmonary embolism (PE)
• Has stable systolic blood pressure (SBP) >90 mm Hg
• Has evidence of right ventricular (RV) dysfunction
• Has executed informed consent

Exclusion Criteria:

• Has history or plans for thrombotic therapy outside protocol allowance

• Has other contraindications for participation

• Has laboratory results outside protocol-specified limits

• Is pregnant, nursing, and/or not willing or able to use protocol-defined contraceptives

• Has history or condition, or participated in another investigational study that (per protocol or in the opinion of the investigator) might compromise:

  1. the safety or well-being of the participant or the participant's offspring
  2. the safety of study staff
  3. the analysis of results