HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: HRS-7450 Injection Placebo; Drug: HRS-7450 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07233070

HRS-7450-201

Details and patient eligibility

About

This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 4 patient groups, including a placebo group

Treatment group A: HRS-7450 Injection

Experimental group

Treatment:

Drug: HRS-7450 Injection

Drug: HRS-7450 Injection

Drug: HRS-7450 Injection

Treatment group B: HRS-7450 Injection

Experimental group

Treatment:

Drug: HRS-7450 Injection

Drug: HRS-7450 Injection

Drug: HRS-7450 Injection

Treatment group C: HRS-7450 Injection

Experimental group

Treatment:

Drug: HRS-7450 Injection

Drug: HRS-7450 Injection

Drug: HRS-7450 Injection

Treatment group D: HRS-7450 Injection Placebo.

Placebo Comparator group

Treatment:

Drug: HRS-7450 Injection Placebo