Safety and Efficacy of J147 in Acute Ischemic Stroke

NCT07430917 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ABRJ147004RZA22630
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; AIS; J147; Stroke; Ischemic Stroke; Endovascular Therapy; EVT; Thrombolytic; Mechanical Thrombectomy; Reperfusion; Recanalization; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Safety of J147 Emulsion for Injection (J147) when administered with endovascular therapy ± intravenous thrombolytic agent in acute ischemic stroke patients.

  Continuous vital signs, 12-Lead ECG, and laboratory assessments will be summarized using descriptive statistics, which includes count, mean, median, standard deviation, min and max by treatment arm and visits. Incidence and severity of adverse events and serious adverse events will be summarized with count and percentages by treatment arm, overall and by System Organ Class and Preferred Term. Deaths will be listed.

  From enrollment to end of study at 90 days.

Secondary Outcomes (4)

• Change from baseline in MRI infarct volumes at 24 h

  24 hours

• Change from baseline in MRI infarct volumes measured at 30 ± 7 days

  30 days

• 72 h NIHSS Score

  72 hours

• 90 day mRS Score

  90 days

Study Arms (6)

Low Dose J147

EXPERIMENTAL

J147 Emulsion for Injection, 1.6 mg/kg

Drug: J147 Emulsion for Injection

Low Dose Placebo

PLACEBO COMPARATOR

Other: Placebo

High Dose J147

EXPERIMENTAL

J147 Emulsion for Injection, 2.5 mg/kg

Drug: J147 Emulsion for Injection

High Dose Placebo

PLACEBO COMPARATOR

Other: Placebo

Target Dose J147

EXPERIMENTAL

J147 Emulsion for Injection

Drug: J147 Emulsion for Injection

Target Dose Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

J147 Emulsion for Injection DRUG

J147 Emulsion for Injection, 20 mg/mL for IV administration, low dose 1.6 mg/kg, high dose 2.5 mg/kg, single IV injection

High Dose J147; Low Dose J147; Target Dose J147

Placebo OTHER

Vehicle without J147, single IV injection

High Dose Placebo; Low Dose Placebo; Target Dose Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 and within 6 hours of symptom discovery.
• Candidates to receive EVT treatment with or 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. Should IV thrombolytic therapy be prematurely halted, the cause and the total administered dose will be recorded. Patients who have received oral anticoagulants (OACs) within the previous 48 hours are not eligible to and should not receive a thrombolytic treatment.
• TICI2B or better recanalization achieved after EVT.
• Females, unless they 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 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. Highly effective methods include:
• Combined (estrogen- and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal, or injectable).
• Progestogen-only hormonal contraception (oral, injectable, or implantable).
• Intrauterine device (IUD).
• Intrauterine hormone-releasing system (IUS).
• Bilateral tubal occlusion.
• Sexual abstinence, if consistent with the participant's usual lifestyle.
• Vasectomized partner, provided the partner is the sole sexual partner and the vasectomy has been confirmed with a negative sperm count.

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 intra-arterial thrombolytic.
• 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.
• Patients that are unlikely to be available for a 90-day follow up.
• Female patients who are pregnant or lactating or are unwilling to use effective methods of contraception.
• Patients with known adverse reaction to J147 or its components.
• Computed tomography (CT) or MRI evidence of acute intracranial hemorrhage (the presence of microbleeds is allowed).
• Significant mass effect with midline shift.
• Imaging evidence or history of intracranial neoplasms except for meningiomas.

Sponsors & Collaborators

• Abrexa Pharmaceuticals, Inc.: lead
• IQVIA RDS Inc.: collaborator

Study Sites (1)

Dell Seton Medical Center at the University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Marguerite Prior, Ph.D.

  Abrexa Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Steven J Warach, MD, PhD

  Dell Seton Medical Center at the University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marguerite Prior, Ph.D.

CONTACT

619-278-9516; mprior@abrexa.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)