HRS-7450 injection for acute ischemic stroke

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of HRS-7450 Injection in Patients With Acute Ischemic Stroke.

This will test whether HRS-7450 injection helps adults 18–80 who have an acute ischemic stroke and arrive 4.5–24 hours after symptoms start.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07233070 on ClinicalTrials.gov

What this trial studies

This Phase II, randomized, placebo-controlled interventional study plans to enroll 208 adults with acute ischemic stroke who present between 4.5 and 24 hours after symptom onset and meet specified imaging criteria. Participants will receive either HRS-7450 injection or placebo and be followed for neurological outcomes and safety, with key eligibility including NIHSS 6–25 and pre-stroke mRS <2. Patients treated with thrombolytics, planned for endovascular therapy, with arterial dissection, multiple large-territory infarcts, or seizure-related deficits are excluded. The trial is being conducted at participating hospitals in China and targets a later treatment window than standard early thrombolysis.

Who should consider this trial

Good fit: Adults aged 18–80 with acute ischemic stroke presenting 4.5–24 hours after symptom onset, NIHSS 6–25, pre-stroke mRS <2, and who meet the study's imaging criteria without planned thrombolytic or endovascular therapy.

Not a fit: Patients outside the 4.5–24 hour window, those already treated with thrombolytics or scheduled for endovascular therapy, or those with arterial dissection, multiple large-territory infarcts, or seizure-related deficits are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If effective, HRS-7450 could improve recovery and functional outcomes for select stroke patients treated in the 4.5–24 hour window.

How similar studies have performed: While late-window thrombectomy trials have shown clear benefit, pharmacologic neuroprotective agents similar to HRS-7450 have had mixed or limited success, so this compound is relatively novel in this setting.

Eligibility criteria

Inclusion Criteria:

1. Fully understand and voluntarily participate in this study, and sign the informed consent form;
2. Aged between 18 and 80 years inclusive (18 ≤ age ≤ 80), regardless of gender;
3. Onset of symptoms within 4.5 to 24 hours;
4. Clinically diagnosed with acute ischemic stroke;
5. Pre-stroke modified Rankin Scale (mRS) score \< 2;
6. National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25 (inclusive) at screening;
7. Meet the imaging inclusion criteria;
8. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective contraception and avoid sperm/ova donation.

Exclusion Criteria:

1. Treatment with thrombolytic therapy.
2. Planned endovascular therapy.
3. Arterial dissection of the head, neck, or aorta.
4. Multiple infarctions across multiple large vascular territories.
5. NIHSS level of consciousness item 1a score \> 2.
6. Neurological deficits presenting after a seizure or post-ictal state, or the presence of other neurological conditions leading to uncooperative or unwillingness to cooperate with examination.
7. Hypodensity exceeding one-third of the middle cerebral artery (MCA) territory on non-contrast CT scan.
8. Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
9. History of intracranial hemorrhagic disease, including but not limited to intracerebral hemorrhage, subarachnoid hemorrhage, etc.
10. History of ischemic stroke, severe head trauma, or intracranial/intraspinal surgery within the past 3 months.
11. Visceral bleeding within the past 3 weeks, including but not limited to gastrointestinal or genitourinary bleeding.
12. Major surgery or severe trauma within the past 2 weeks.
13. Arterial puncture at a non-compressible site within the past week.
14. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg despite aggressive antihypertensive treatment.
15. Known significant bleeding tendency or severe coagulation disorder.
16. Blood glucose at screening \>22.2 mmol/L or \<2.8 mmol/L; subjects may be re-evaluated after active treatment.
17. Within the past 3 months: acute ST-segment elevation myocardial infarction (MI), and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or hospitalization for acute coronary syndrome, MI, cardiac arrest, or unplanned coronary intervention; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia.
18. Significant liver disease history, or AST and/or ALT and/or GGT ≥3 × ULN, and/or total bilirubin (TBIL) ≥2 × ULN, or known congenital disorder of bilirubin metabolism.
19. Clinically significant severe renal disease, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m².
20. History of hemolytic anemia due to various causes, currently under treatment or not meeting cure criteria.
21. Known allergy or hypersensitivity to HRS-7450 or any excipients in its formulation.
22. Treatment with therapeutic doses of heparin or low molecular weight heparin within 24 hours.
23. Use of oral anticoagulants within 48 hours, including vitamin K antagonists, direct thrombin inhibitors, factor Xa inhibitors, or other investigational anticoagulants.
24. Use of glycoprotein IIb/IIIa receptor inhibitors within 48 hours.
25. Female subjects who are pregnant or breastfeeding, or with a positive pregnancy test.
26. Participation in another drug or device clinical trial within the 3 months prior to screening.
27. Terminal illness with a life expectancy of less than 1 year.
28. Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Yu Gao

Conditions Acute Ischemic Stroke