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

NCT ID: NCT07233070

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-01-31

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A: HRS-7450 Injection

Group Type: EXPERIMENTAL

HRS-7450 Injection

Intervention Type: DRUG

HRS-7450 Injection; low dose

Treatment group B: HRS-7450 Injection

Group Type: EXPERIMENTAL

HRS-7450 Injection

Intervention Type: DRUG

HRS-7450 Injection; Intermediate dose

Treatment group C: HRS-7450 Injection

Group Type: EXPERIMENTAL

HRS-7450 Injection

Intervention Type: DRUG

HRS-7450 Injection; high dose

Treatment group D: HRS-7450 Injection Placebo.

Group Type: PLACEBO_COMPARATOR

HRS-7450 Injection Placebo

Intervention Type: DRUG

HRS-7450 Injection Placebo

Interventions

HRS-7450 Injection

HRS-7450 Injection; low dose

Intervention Type: DRUG

HRS-7450 Injection

HRS-7450 Injection; Intermediate dose

Intervention Type: DRUG

HRS-7450 Injection

HRS-7450 Injection; high dose

Intervention Type: DRUG

HRS-7450 Injection Placebo

HRS-7450 Injection Placebo

Intervention Type: DRUG

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Linyi People's Hospital

Linyi, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Gao

Role: CONTACT

yu.gao.yg5@hengrui.com

+0518-82342973

Other Identifiers

HRS-7450-201

Identifier Type: -

Identifier Source: org_study_id