Safety and Efficacy of J147 in Acute Ischemic Stroke

Part of paid clinical trials in Austin, Texas.

Sponsor
Abrexa Pharmaceuticals, Inc.
Study ID
NCT07430917
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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
  • Placebo — OTHER
    Vehicle without J147, single IV injection

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose J147
    J147 Emulsion for Injection, 1.6 mg/kg
  • Placebo Comparator: Low Dose Placebo
  • Experimental: High Dose J147
    J147 Emulsion for Injection, 2.5 mg/kg
  • Placebo Comparator: High Dose Placebo
  • Experimental: Target Dose J147
    J147 Emulsion for Injection
  • Placebo Comparator: Target Dose Placebo

Primary Outcome Measure

Safety of J147 Emulsion for Injection (J147) when administered with endovascular therapy in acute ischemic stroke patients. [ Time Frame: From enrollment to end of study at 90 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dell Seton Medical Center at the University of Texas at AustinAustinTexas78712
Lisa A Davis, PhD, RN
[email protected]
512-202-6486
Steven J Warach, MD, PhD (PRINCIPAL_INVESTIGATOR)
Elham Askari, MD (SUB_INVESTIGATOR)
Zachary Brittingham, DO (SUB_INVESTIGATOR)
Lisa Davis, PhD, RN (SUB_INVESTIGATOR)
Supreet Kaur, MD (SUB_INVESTIGATOR)
Manzure Mawla, DO (SUB_INVESTIGATOR)
Jefferson Miley, MD (SUB_INVESTIGATOR)
Matthew Padrick, MD (SUB_INVESTIGATOR)
Rachel Pearson, MD (SUB_INVESTIGATOR)
Hamidreza Saber, MD (SUB_INVESTIGATOR)
Borna Tabibian, MD (SUB_INVESTIGATOR)

Find similar trials in Austin, TX

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Dell Seton Medical Center at the University of Texas at Austin· Austin, TX

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