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

NCT02923115 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-04-19

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Study Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-23
Primary Completion
2019-08-05
Completion
2019-08-05

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02923115 on ClinicalTrials.gov