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


Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Men and women 18 years of age and older.
- Subjects have a clinical diagnosis of acute ischemic stroke (including lacunar stroke) supported by computed topography or magnetic resonance imaging.
- Subjects have stroke symptoms onset within 4.5 to 12 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptoms onset time refers to the last time the subject was known to be well.
- Subjects have a NIHSS score of ≥ 2.
- Subjects, (or their legally authorized representative-where applicable and based on country-specific practice), must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping.

Exclusion Criteria

- Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke.
Eligible subjects declining these treatments can be enrolled to this study.
- Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]).
- Subjects have symptoms of subarachnoid hemorrhage, even with normal CT.
- Subjects have an Alberta Stroke Program Early CT Score (ASPECTS) < 6.
- Subjects have prior non-traumatic intracranial hemorrhage (excluding microhemorrahages observed in imaging).
- Subjects have known arteriovenous malformation or aneurysm.
- Subjects have evidence of active bleeding.
- Subjects have platelet count < 100,000.
- Subjects have International Normalized Ratio > 1.7.
- Subjects have used unfractionated heparin within 24 hours prior to treatment and have an elevated partial thromboplastin time.
- Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours prior to treatment.
- Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment.
- Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging.
- Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit).
- Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month.
- Subjects have had major surgery within 14 days.
- Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days.
- Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days.
- Subjects have a preexisting disability classified by mRS > 2.
- Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2.
- Subjects have baseline hemoglobin < 10.5 g/dL.
- Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age).
- Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug.
- Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO ((INC Research), or the Site.
- Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.