Acute Ischemic StrokePhase 2NCT07233070

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

A Phase 2 study testing HRS-7450 Injection in people with Acute Ischemic Stroke, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Ischemic Stroke
What is being tested?: HRS-7450 Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 210 participants
Where: 2 sitesChina
Study dates: 31 Oct 2025to 17 Sep 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Treatment with thrombolytic therapy.
Planned endovascular therapy.
Arterial dissection of the head, neck, or aorta.
Multiple infarctions across multiple large vascular territories.
NIHSS level of consciousness item 1a score > 2.
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.

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Hypodensity exceeding one-third of the middle cerebral artery (MCA) territory on non-contrast CT scan.
Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
History of intracranial hemorrhagic disease, including but not limited to intracerebral hemorrhage, subarachnoid hemorrhage, etc.
History of ischemic stroke, severe head trauma, or intracranial/intraspinal surgery within the past 3 months.
Visceral bleeding within the past 3 weeks, including but not limited to gastrointestinal or genitourinary bleeding.
Major surgery or severe trauma within the past 2 weeks.
Arterial puncture at a non-compressible site within the past week.
Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg despite aggressive antihypertensive treatment.
Known significant bleeding tendency or severe coagulation disorder.
Blood glucose at screening >22.2 mmol/L or <2.8 mmol/L; subjects may be re-evaluated after active treatment.
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.
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.
Clinically significant severe renal disease, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
History of hemolytic anemia due to various causes, currently under treatment or not meeting cure criteria.
Known allergy or hypersensitivity to HRS-7450 or any excipients in its formulation.
Treatment with therapeutic doses of heparin or low molecular weight heparin within 24 hours.
Use of oral anticoagulants within 48 hours, including vitamin K antagonists, direct thrombin inhibitors, factor Xa inhibitors, or other investigational anticoagulants.
Use of glycoprotein IIb/IIIa receptor inhibitors within 48 hours.
Female subjects who are pregnant or breastfeeding, or with a positive pregnancy test.
Participation in another drug or device clinical trial within the 3 months prior to screening.
Terminal illness with a life expectancy of less than 1 year.
Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510062
Linyi People's Hospital
Linyi, Shandong, 276002

Other trials in China

About this study

Official title: 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.

Conditions: Acute Ischemic Stroke
Being tested: HRS-7450 Injection, HRS-7450 Injection Placebo
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-7450 InjectionDrug
HRS-7450 Injection; low dose
HRS-7450 InjectionDrug
HRS-7450 Injection; Intermediate dose
HRS-7450 InjectionDrug
HRS-7450 Injection; high dose
HRS-7450 Injection PlaceboDrug
HRS-7450 Injection Placebo

Study groups in NCT07233070
Study group	Role	What they receive
Treatment group A: HRS-7450 Injection	Experimental	Not described Receives: Drug: HRS-7450 Injection
Treatment group B: HRS-7450 Injection	Experimental	Not described Receives: Drug: HRS-7450 Injection
Treatment group C: HRS-7450 Injection	Experimental	Not described Receives: Drug: HRS-7450 Injection
Treatment group D: HRS-7450 Injection Placebo.	Placebo comparator	Not described Receives: Drug: HRS-7450 Injection Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

mRS score of 0-1 at 90 days
Measured: within 90 days after the start of administration

Secondary outcomes (16)

Reperfusion rate at 24 hours;
Measured: within 24 hours after the start of administration
Recanalization rate at 24 hours;
Measured: 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;
Measured: within 24 hours after the start of administration
Infarct volume at 7 days;
Measured: 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;
Measured: within 7 days after the start of administration
NIHSS score at 14 days;
Measured: within 14 days after the start of administration
mRS score at 90 days;
Measured: within 90 days after the start of administration
Proportion of subjects with mRS score 0-2 at 90 days;
Measured: within 90 days after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing;
Measured: within 36 hours after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 7 days after dosing;
Measured: within 7 days after the start of administration
Incidence of intracranial hemorrhage (ICH) within 36 hours after dosing;
Measured: within 36 hours after the start of administration
Incidence of intracranial hemorrhage (ICH) within 7 days after dosing;
Measured: within 7 days after the start of administration
Incidence of major non-intracranial hemorrhage within 36 hours after dosing;
Measured: within 36 hours after the start of administration
Incidence of major non-intracranial hemorrhage within 7 days after dosing;
Measured: within 7 days after the start of administration
Mortality rate at 7 days after dosing;
Measured: within 7 days after the start of administration
Mortality rate at 90 days after dosing;
Measured: within 90 days after the start of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202517 Sep 2026

First posted18 Nov 2025
Study start31 Oct 2025
Primary completion17 Sep 2026
Study completion17 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07233070
Sponsor's protocol ID: HRS-7450-201
Status last verified: Oct 2025
First submitted: 14 Nov 2025
Last updated: 20 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07233070
Acronym / sponsor ID: HRS-7450-201
Conditions: Acute Ischemic Stroke
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 31 Oct 2025 (actual)
Primary completion: 17 Sep 2026 (actual)
Study completion: 17 Sep 2026 (actual)
First posted: 18 Nov 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment group A: HRS-7450 Injection	Experimental	Drug: HRS-7450 Injection
Treatment group B: HRS-7450 Injection	Experimental	Drug: HRS-7450 Injection
Treatment group C: HRS-7450 Injection	Experimental	Drug: HRS-7450 Injection
Treatment group D: HRS-7450 Injection Placebo.	Placebo comparator	Drug: HRS-7450 Injection Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Fully understand and voluntarily participate in this study, and sign the informed consent form;
Aged between 18 and 80 years inclusive (18 ≤ age ≤ 80), regardless of gender;
Onset of symptoms within 4.5 to 24 hours;
Clinically diagnosed with acute ischemic stroke;
Pre-stroke modified Rankin Scale (mRS) score < 2;

Key exclusion criteria (28 listed)

Treatment with thrombolytic therapy.
Planned endovascular therapy.
Arterial dissection of the head, neck, or aorta.
Multiple infarctions across multiple large vascular territories.
NIHSS level of consciousness item 1a score > 2.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-7450 InjectionHRS-7450 Injection; low dose	Drug	Treatment group A: HRS-7450 Injection
HRS-7450 InjectionHRS-7450 Injection; Intermediate dose	Drug	Treatment group B: HRS-7450 Injection
HRS-7450 InjectionHRS-7450 Injection; high dose	Drug	Treatment group C: HRS-7450 Injection
HRS-7450 Injection PlaceboHRS-7450 Injection Placebo	Drug	Treatment group D: HRS-7450 Injection Placebo.

Primary outcome

mRS score of 0-1 at 90 days
Time frame: within 90 days after the start of administration

16 secondary outcomes

Reperfusion rate at 24 hours;
Time frame: within 24 hours after the start of administration
Recanalization rate at 24 hours;
Time frame: 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;
Time frame: within 24 hours after the start of administration
Infarct volume at 7 days;
Time frame: 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;
Time frame: within 7 days after the start of administration
NIHSS score at 14 days;
Time frame: within 14 days after the start of administration
mRS score at 90 days;
Time frame: within 90 days after the start of administration
Proportion of subjects with mRS score 0-2 at 90 days;
Time frame: within 90 days after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing;
Time frame: within 36 hours after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 7 days after dosing;
Time frame: within 7 days after the start of administration
Incidence of intracranial hemorrhage (ICH) within 36 hours after dosing;
Time frame: within 36 hours after the start of administration
Incidence of intracranial hemorrhage (ICH) within 7 days after dosing;
Time frame: within 7 days after the start of administration
Incidence of major non-intracranial hemorrhage within 36 hours after dosing;
Time frame: within 36 hours after the start of administration
Incidence of major non-intracranial hemorrhage within 7 days after dosing;
Time frame: within 7 days after the start of administration
Mortality rate at 7 days after dosing;
Time frame: within 7 days after the start of administration
Mortality rate at 90 days after dosing;
Time frame: within 90 days after the start of administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Acute Ischemic Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS-7450 Injection in people with Acute Ischemic Stroke, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mRS score of 0-1 at 90 days (time frame: within 90 days after the start of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07233070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.