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
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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