NCT02923115

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

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Embolism
• Thrombotic Disease

Interventions

Type	Name	Description
DRUG	DS-1040b	Single, continuous intravenous infusion over 12 to 24 hours (depending on cohort)
DRUG	Placebo	Single, continuous intravenous infusion of 0.9% sodium chloride over 12 to 24 hours
DRUG	Enoxaparin	Subcutaneous injection 1 mg/kg twice daily

Timeline

• Start date: 2016-06-23
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2016-10-04
• Last updated: 2023-04-19
• Results posted: 2020-07-30

Locations

46 sites across 8 countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain