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Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

NCT02586233 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2020-09-09

Study results available
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Summary

This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).

Conditions

  • Acute Ischemic Stroke
  • Thrombotic Disease

Interventions

DRUG

DS-1040b

DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period

DRUG

Placebo

0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-08-13
Completion
2019-08-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • France
  • Germany
  • Italy
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02586233 on ClinicalTrials.gov