Safety and Efficacy of J147 in Acute Ischemic Stroke

NCT07430917 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

DRUG

J147 Emulsion for Injection

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

OTHER

Placebo

Vehicle without J147, single IV injection

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY
  • Abrexa Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Marguerite Prior, Ph.D. · Abrexa Pharmaceuticals, Inc.

  • Steven J Warach, MD, PhD · Dell Seton Medical Center at the University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2028-03-01
Completion
2028-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430917 on ClinicalTrials.gov