Safety and Efficacy of J147 in Acute Ischemic Stroke

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.