NCT07430917

Safety and Efficacy of J147 in Acute Ischemic Stroke

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Adaptive Study to Assess the Safety and Efficacy of Intravenous J147 Combined With Endovascular Therapy in Patients With Acute Ischemic Stroke

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Abrexa Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, adaptive Phase II clinical study to evaluate the administration of J147 Emulsion for Injection (J147) in patients with acute ischemic stroke (AIS) with confirmed large vessel occlusion who undergo mechanical thrombectomy without intravenous thrombolytic therapy (alteplase or tenecteplase) and are candidates for reperfusion therapies. Participants will undergo mechanical thrombectomy per standard of care. Following confirmation of successful reperfusion, eligible participants will receive a single intravenous bolus injection of blinded J147 Emulsion for Injection or placebo. The study will be conducted in two sequential cohorts. In the first cohort, two dose levels of J147 will be evaluated in comparison with placebo. Based on an interim safety and efficacy review conducted by an independent Data Safety Monitoring Board (DSMB), a target dose will be selected for evaluation in the second cohort. Participants in the second cohort will be randomized to receive the selected dose of J147 or placebo. The objective of the study is to evaluate the safety and tolerability of J147 at different dose levels compared with placebo when administered in combination with mechanical thrombectomy without intravenous thrombolytic therapy, and to explore its potential effects on imaging, biological, and clinical outcomes in the AIS target population.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-20
• Primary completion: 2028-03-01
• Completion: 2028-07-01
• First posted: 2026-02-24
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study