A Phase 1b/2, Multi-Centre, Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects with Acute Ischemic Stroke
Lead PI: Dr Bruce Campbell
Status: Recruiting Closed
No. of Patients Currently Recruited: 130 No. of Patients Required: 130
This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded, Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-centre study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of DS-1040b in subjects with acute ischemic stroke. The primary aim of the study is to assess the safety and tolerability of DS-1040b (intravenous infusion over 6 hours) in subjects with acute ischemic stroke within 4.5 to 12 hours after stroke symptoms onset.
Trial URL: https://www.clinicaltrials.gov/ct2/show/study/NCT02586233