At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 106 enrolled
Drug / intervention
DS-1040b +1 moredrug
Likely dose
DS-1040b 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
In Brief
A Phase 2 clinical trial evaluating DS-1040b and Placebo for Acute Ischemic Stroke and Thrombotic Disease. Completed, enrolled 106 participants across 55 sites in 11 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke, Thrombotic Disease
CountriesAustralia, Czechia, France, Germany, Italy, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedOct 2015
Primary CompletionAug 2019
TodayJul 2026
First PostedOct 26, 2015
Enrollment StartSep 1, 2015
Primary CompletionAug 13, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.7 years ago
Interventions
DS-1040bdrug
DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period
Placebodrug
0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period