Safety, Tolerability, and Preliminary Efficacy of HRS-7450 Injection in the Treatment of Acute Ischemic Stroke: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled Clinical Trial

Safety, Tolerability, and Preliminary Efficacy of HRS-7450 Injection in the Treatment of Acute Ischemic Stroke: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Single Dose Incremental Phase Ib Clinical Trial

This study is a multi-center, randomized, double-blind, double-dummy, placebo-controlled, single dose escalation study aimed at evaluating the overall safety, tolerability, and preliminary efficacy of HRS-7450 in patients with acute ischemic stroke.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: HRS-7450; Drug: 0.9% sodium chloride injection

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510062
      • The First Affiliated Hospital of Sun Yat sen University

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 an informed consent form (the informed consent form can be voluntarily signed by the individual or legal representative);
2. 18 ≤ Age ≤ 80 years old;
3. The onset time is within 4.5 to 24 hours, and medication can be completed within 24 hours of onset (onset time is defined as the patient's last normal time);
4. Clinically diagnosed as acute ischemic stroke (diagnosis follows the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023);
5. mRS score ≤ 2 before the first episode;
6. When screening, the National Institutes of Health Stroke Scale (NIHSS) scores from 3 to 25 (including both ends);
7. Female and male participants with fertility must agree to use efficient contraception measures from the signing of the informed consent form until one month after the last administration of the investigational drug, without a birth plan, and without donating sperm/eggs. (See "Contraceptive methods" in the attachment for details).

Exclusion Criteria:

1. Treatment with ateplase, teneplase, or other thrombolytic drugs;
2. Proposed endovascular treatment;
3. Intracranial hemorrhagic diseases;
4. Aortic arch dissection;
5. NIHSS awareness score 1a>2 points;
6. Epileptic seizures or neurological dysfunction after seizures, or combined with other neurological/psychiatric disorders leading to uncooperative or non cooperative physical examinations;
7. Non enhanced CT shows a low-density shadow greater than one-third of the blood supply area of the middle cerebral artery or an ASPECT score of less than 6 points in the anterior circulation;
8. Previous history of intracranial hemorrhage;
9. Intracranial tumors, arteriovenous malformations, and giant aneurysms;
10. Acute occlusion of the internal carotid artery due to carotid artery dissection;
11. Multiple infarcts in areas supplied by multiple large blood vessels;
12. Have a history of ischemic stroke, severe traumatic brain injury, or intracranial or spinal surgery in the past month;
13. Gastrointestinal or urinary system bleeding within the past 2 weeks;
14. Major surgical procedures or severe injuries within the past 2 weeks;
15. Arterial puncture that is difficult to compress and stop bleeding within the past week;
16. Active visceral bleeding;
17. After actively reducing blood pressure, systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 100mmHg;
18. Screening period examination: Blood glucose<2.8 or>22.2mmol/L, platelet<100 * 109/L, other findings suggestive of a high risk of bleeding;
19. Within the past 3 months, acute ST segment elevation myocardial infarction (MI) and/or acute decompensated heart failure occurred, and/or QTc>520 milliseconds, and/or due to acute coronary syndrome MI、 Hospitalization or involuntary coronary intervention for cardiac arrest; Or New York Heart Association Grade III/IV heart failure; Or known to have ventricular tachycardia;
20. History of severe liver disease, or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or glutamyltransferase (GGT) ≥ 3 x ULN and/or total bilirubin (TBIL) ≥ 2 x ULN.
21. Severe kidney disease with clinical significance, or eGFR<45mL/min/1.73 m2;
22. Subjects with known potential bleeding constitution or coagulation dysfunction;
23. Subjects with a known history of glucose-6-phosphate dehydrogenase deficiency or a family history;
24. Known to be allergic to any component of HRS-7450 or its formulations or placebo;
25. Received therapeutic or prophylactic doses of heparin treatment within 24 hours;
26. Oral coumarin anticoagulants with an international standardized ratio INR>2.7;
27. Use thrombin inhibitors, Xa factor inhibitors, or other anticoagulant drugs under study within48 hours;
28. Use platelet IIb/IIIa receptor inhibitors within 48 hours;
29. Pregnant women, or women of childbearing age who test positive for pregnancy, or those who are breastfeeding;
30. Participate in clinical studies of other drugs or devices within the first three months of the screening period (sign an informed consent form and receive treatment with the trial drug/device);
31. The terminal state of the disease, with an expected survival period of no more than 1 year;
32. Other situations where the researcher deems it inappropriate to participate in this experiment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-7450	Drug: HRS-7450; HRS-7450 Injection
Placebo Comparator: 0.9% sodium chloride injection	Drug: 0.9% sodium chloride injection; 0.9% sodium chloride injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptomatic Intracranial Hemorrhage within 36 hours after the start of administration, The incidence of sICH	within 36 hours after the start of administration

Secondary Outcome Measures

Outcome Measure	Time Frame
7 day mortality rate after administration	within 7days after the start of administration
The incidence of sICH 7 days after administration	within 7days after the start of administration
The incidence of ICH 7 days after administration	within 7days after the start of administration
The incidence of systemic bleeding 7 days after administration	within 7days after the start of administration
Effective reperfusion rate measured by 24-hour PWI or CTP	within 24 hours after the start of administration
24-hour MRA or CTA measurement of vascular reperfusion rate	within 24 hours after the start of administration
Infarct core volume measured by CT or MRI at 5-7 days	within 5-7days after the start of administration
24-hour NIHSS score change	within 24 hours after the start of administration
24-hour good response rate (NIHSS score reduction greater than 8 points, or NIHSS score 0-1)	within 24 hours after the start of administration
7 day NIHSS score change	within 7days after the start of administration
7 day good response rate (NIHSS score reduction greater than 8 points, or NIHSS score 0-1)	within 7days after the start of administration

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): March 18, 2025
• Study Completion (Actual): June 11, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 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; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: HRS-7450-102

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