drugset / Trial / NCT02923115
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.
Timeline
- Start
- 2016-06-23
- Primary completion
- 2019-08-05
- Completion
- 2019-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DS-1040b | Small molecule | 3 mg | Intravenous |
| Subject | DS-1040b | Small molecule | 6 mg | Intravenous |
| Background | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |