A Phase I, Single Blind, Placebo-controlled, Randomized Study to Assess the Safety of DS-1040b in Subjects With Thrombectomy Treated Acute Ischemic Stroke.
A Phase I, Single Blind, Placebo-controlled, Randomized Study to Assess the Safety of DS-1040b in Subjects With Thrombectomy Treated Acute Ischemic Stroke.
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.
Inclusion Criteria:
Exclusion Criteria:
Has treatment plan that includes fibrinolysis or fibinolysis
Has identified intracranial hemorrhage or subarachnoid hemorrhage
Has active bleeding like gastrointestinal hemorrhage
Has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
Has severe hepatic or renal impairment
Has been a participant in other clinical trial within 30 days prior to treatment
Is pregnant, lactating, or planning on becoming pregnant during treatment period
Has any condition or history that might, per protocol or in the opinion of the investigator, compromise:
Amagasaki, Hyōgo 660-8511, Japan