Safety and Efficacy of J147 in Acute Ischemic Stroke
Eligible age
18–90 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
The goal of this clinical trial is to find out if the drug J147 improves outcomes for persons who have had an ischemic stroke. It also will learn about the safety of J147 when given by injection to stroke patients. Researchers will compare the outcomes of those who receive J147 after therapy to clear the blood clot to those who don't receive J147. Participants will be asked to undergo a series of three to four magnetic resonance imaging (MRI) brain scans, and blood samples will be collected at several time points. Participants will also be evaluated to measure several aspects of brain function.
Sponsor: Abrexa Pharmaceuticals, Inc.
You may qualify if…
- ✓ Signed informed consent obtained from the patient or legally authorized representative.
- ✓ A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- ✓ Baseline NIHSS ≥5 and ≤25 points obtained prior to randomization with a disabling neurological deficit as determined by clinical judgement.
- ✓ Pre-stroke mRS score of 0-2.
- ✓ Availability to be treated within 24 hours of last known well.
- ✓ Candidates to receive EVT treatment without IV thrombolytic therapy. Such patients should be initiated as recommended by the local standard of care for the early management of patients with AIS.
- ✓ eTICI or better reperfusion achieved after completion of EVT.
- ✓ Females, unless they are permanently sterile (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal (defined as no menses for at least 12 consecutive months without an alternative medical cause and, when applicable, confirmed by serum follicle stimulating hormone \[FSH\] level) must agree to use highly effective methods of contraception during the study and for a minimum of 30 days after the last dose of study drug. In women aged \<45 years who report being postmenopausal, postmenopausal status must be confirmed by a serum FSH level in the postmenopausal range according to the laboratory's reference values. Until postmenopausal status is confirmed, these participants must remain abstinent or use a highly effective method of contraception. Highly effective methods include:
You may not qualify if…
- ✕ Absolute contraindication to MRI with gadolinium contrast.
- ✕ Serious, advanced, or terminal illness with an anticipated life expectancy of \<6 months.
- ✕ History of life-threatening allergy (more than rash) to contrast medium.
- ✕ Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) of \<30 mL/min.
- ✕ Clinically significant hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper level of normal (ULN) and/or total bilirubin \>1.5× ULN, unless attributable to a known diagnosis of Gilbert's syndrome without other evidence of liver dysfunction.
- ✕ Patients that have received intravenous or intra-arterial thrombolytic for the current stroke prior to mechanical thrombectomy.
- ✕ Patients participating in a study involving an investigational drug or device.
- ✕ Any clinically significant medical history, physical examination finding, laboratory abnormality, vital sign abnormality, or 12-Lead ECG finding that, in the opinion of the investigator, may pose a risk to the patient's safety or well-being, interfere with the patient's ability to participate fully in the study, or confound the interpretation of study results.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07430917 · last updated 2026-08-24