Research Background: The HRS-7450 Injection is being studied for the treatment of acute ischemic stroke (commonly known as “cerebral infarction”). This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the safety and efficacy of HRS-7450 Injection in patients with acute ischemic stroke. The study primarily targets patients with acute ischemic stroke who present within 4.5 to 24 hours after symptom onset.

　　Note: For acute stroke patients who present beyond 4.5 hours after symptom onset, although they have missed the time window for traditional intravenous thrombolytic therapy, participation in this study may still have an opportunity to receive intravenous thrombolytic therapy.

　　Key Inclusion Criteria:

　　Aged 18–80 years; 

　　Time duration from symptom onset to administration of the investigational drug: 4.5–24 hours;

　　Stroke severity measured based on NIH Stroke Scale (NIHSS): Scoring 6–25;

　　Imaging results show that there is still salvageable brain tissue (infarct core volume <70 mL and mismatch ratio >1.8);

　　Pre-stroke functional status: mostly independent in daily living, modified Rankin Scale (mRS) score <2. 

　　Key Exclusion Criteria:

　　Patients who have already received thrombolytic therapy or undergone mechanical thrombectomy before enrollment; 

　　Have history of intracranial hemorrhage or experienced recent traumatic brain injury; 

　　Undergone recent major surgery or experienced severe trauma;

　　Presence of severe cardiac, hepatic, or renal dysfunction

　　Known allergy to the investigational drug or any of its ingredients/excipients;

　　Study Design: The clinical trial is a randomized, double-blind, placebo-controlled study. The investigational drug will be administered as a single intravenous infusion. The study includes a screening period, treatment period, and a 90-day follow-up period.

　　If you or someone you know meets the above criteria and is interested in participating in this clinical trial, please contact: Dr. SUN Wei.
Tel: +86 133 1650 9177.