A Phase 1b/2 study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 96

Inclusion Criteria

1. Subjects have a clinical diagnosis of ischemic stroke with middle cerebral artery (MCA) occlusion (M1 or M2), as demonstrated by computed tomography (CT) angiography or magnetic resonance (MR) angiography.
2. Men and women 18 to 80 years of age, inclusive.
3. Subjects have stroke symptom onset within 3 to 8 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptom onset time refers to the last time the subject was known to be well.
4. Subjects have a NIHSS score > 4 and < 22.
5. Subjects have a body weight of 50 kg to 120 kg, inclusive.
6. Subjects, or their legally authorized representative, 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1. Subjects have evidence of intracranial hemorrhage on non-contrast CT (or MR).
2. Subjects have symptoms of subarachnoid hemorrhage, even with normal CT.
3. Subjects have evidence of large MCA territory infarction (sulcal effacement or blurring of gray white junction in greater than 1/3 of MCA territory).
4. Subjects have prior non-traumatic intracranial hemorrhage.
5. Subjects have known arteriovenous malformation or aneurysm.
6. Subjects have evidence of active bleeding.
7. Subjects have platelet count < 100,000.
8. Subjects have International Normalized Ratio > 1.7.
9. Subjects have used heparin within 48 hours or have an elevated partial thromboplastin time.
10. Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours.
11. Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 48 hours.
12. Subjects with anticipated use 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.
13. Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke.
14. 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).
15. Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 3 months.
16. Subjects have had major surgery within 14 days.
17. Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days.
18. Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days.
19. Subjects have a preexisting disability classified by mRS > 1.
20. Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2.
21. Subjects have baseline haemoglobin < 10.5 g/dL.
22. Subjects have a positive pregnancy test. Serum pregnancy tests will be performed in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age).
23. 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.
24. Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO (PAREXEL), or the Site.
25. Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 8/30/2021

A Phase 1b/2 study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke.

Recruitment & Eligibility

Study & Design

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