HRS-7450 Injection Phase II Clinical Trial 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 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: HRS-7450 Injection; Drug: HRS-7450 Injection; Drug: HRS-7450 Injection; Drug: HRS-7450 Injection Placebo

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yu Gao; Phone Number: +0518-82342973; Email: yu.gao.yg5@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510062
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Principal Investigator: Jinsheng Zeng
  • Shandong
    • Linyi, Shandong, China, 276002
      • Recruiting
      • Linyi people's hospital
      • Principal Investigator: Ziran Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-7450 Injection	Drug: HRS-7450 Injection; HRS-7450 Injection; low dose; Drug: HRS-7450 Injection; HRS-7450 Injection; Intermediate dose; Drug: HRS-7450 Injection; HRS-7450 Injection; high dose
Experimental: Treatment group B: HRS-7450 Injection	Drug: HRS-7450 Injection; HRS-7450 Injection; low dose; Drug: HRS-7450 Injection; HRS-7450 Injection; Intermediate dose; Drug: HRS-7450 Injection; HRS-7450 Injection; high dose
Experimental: Treatment group C: HRS-7450 Injection	Drug: HRS-7450 Injection; HRS-7450 Injection; low dose; Drug: HRS-7450 Injection; HRS-7450 Injection; Intermediate dose; Drug: HRS-7450 Injection; HRS-7450 Injection; high dose
Placebo Comparator: Treatment group D: HRS-7450 Injection Placebo.	Drug: HRS-7450 Injection Placebo; HRS-7450 Injection Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mRS score of 0-1 at 90 days	within 90 days after the start of administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Reperfusion rate at 24 hours;	within 24 hours after the start of administration
Recanalization rate at 24 hours;	within 24 hours after the start of administration
Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 24 hours;	within 24 hours after the start of administration
Infarct volume at 7 days;	within 7 days after the start of administration
Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 7 days;	within 7 days after the start of administration
NIHSS score at 14 days;	within 14 days after the start of administration
mRS score at 90 days;	within 90 days after the start of administration
Proportion of subjects with mRS score 0-2 at 90 days;	within 90 days after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing;	within 36 hours after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 7 days after dosing;	within 7 days after the start of administration
Incidence of intracranial hemorrhage (ICH) within 36 hours after dosing;	within 36 hours after the start of administration
Incidence of intracranial hemorrhage (ICH) within 7 days after dosing;	within 7 days after the start of administration
Incidence of major non-intracranial hemorrhage within 36 hours after dosing;	within 36 hours after the start of administration
Incidence of major non-intracranial hemorrhage within 7 days after dosing;	within 7 days after the start of administration
Mortality rate at 7 days after dosing;	within 7 days after the start of administration
Mortality rate at 90 days after dosing;	within 90 days after the start of administration

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: HRS-7450-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No