Acute Ischemic StrokePhase 1NCT06447415
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
A Phase 1 study testing HRS-7450 and 0.9% sodium chloride injection in people with Acute Ischemic Stroke, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. 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 and 0.9% sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 11 Jun 2025
- Phase
- Phase 1
- 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 an informed consent form (the informed consent form can be voluntarily signed by the individual or legal representative);
- 18 ≤ Age ≤ 80 years old;
- 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);
- Clinically diagnosed as acute ischemic stroke (diagnosis follows the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023);
- mRS score ≤ 2 before the first episode;
- When screening, the National Institutes of Health Stroke Scale (NIHSS) scores from 3 to 25 (including both ends);
- 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).
Who cannot join
- Treatment with ateplase, teneplase, or other thrombolytic drugs;
- Proposed endovascular treatment;
- Intracranial hemorrhagic diseases;
- Aortic arch dissection;
- NIHSS awareness score 1a>2 points;
- Epileptic seizures or neurological dysfunction after seizures, or combined with other neurological/psychiatric disorders leading to uncooperative or non cooperative physical examinations;
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- 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;
- Previous history of intracranial hemorrhage;
- Intracranial tumors, arteriovenous malformations, and giant aneurysms;
- Acute occlusion of the internal carotid artery due to carotid artery dissection;
- Multiple infarcts in areas supplied by multiple large blood vessels;
- Have a history of ischemic stroke, severe traumatic brain injury, or intracranial or spinal surgery in the past month;
- Gastrointestinal or urinary system bleeding within the past 2 weeks;
- Major surgical procedures or severe injuries within the past 2 weeks;
- Arterial puncture that is difficult to compress and stop bleeding within the past week;
- Active visceral bleeding;
- After actively reducing blood pressure, systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 100mmHg;
- Screening period examination: Blood glucose<2.8 or>22.2mmol/L, platelet<100 * 109/L, other findings suggestive of a high risk of bleeding;
- 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;
- 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.
- Severe kidney disease with clinical significance, or eGFR<45mL/min/1.73 m2;
- Subjects with known potential bleeding constitution or coagulation dysfunction;
- Subjects with a known history of glucose-6-phosphate dehydrogenase deficiency or a family history;
- Known to be allergic to any component of HRS-7450 or its formulations or placebo;
- Received therapeutic or prophylactic doses of heparin treatment within 24 hours;
- Oral coumarin anticoagulants with an international standardized ratio INR>2.7;
- Use thrombin inhibitors, Xa factor inhibitors, or other anticoagulant drugs under study within48 hours;
- Use platelet IIb/IIIa receptor inhibitors within 48 hours;
- Pregnant women, or women of childbearing age who test positive for pregnancy, or those who are breastfeeding;
- 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);
- The terminal state of the disease, with an expected survival period of no more than 1 year;
- Other situations where the researcher deems it inappropriate to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, 510062
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- HRS-7450, 0.9% sodium chloride injection
- 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-7450Drug
HRS-7450 Injection
0.9% sodium chloride injectionDrug
0.9% sodium chloride injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-7450 | Experimental | Not described Receives: Drug: HRS-7450 |
| 0.9% sodium chloride injection | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Intracranial Hemorrhage within 36 hours after the start of administration, The incidence of sICH
Measured: within 36 hours after the start of administration
Secondary outcomes (11)
7 day mortality rate after administration
Measured: within 7days after the start of administration
The incidence of sICH 7 days after administration
Measured: within 7days after the start of administration
The incidence of ICH 7 days after administration
Measured: within 7days after the start of administration
The incidence of systemic bleeding 7 days after administration
Measured: within 7days after the start of administration
Effective reperfusion rate measured by 24-hour PWI or CTP
Measured: within 24 hours after the start of administration
24-hour MRA or CTA measurement of vascular reperfusion rate
Measured: within 24 hours after the start of administration
Infarct core volume measured by CT or MRI at 5-7 days
Measured: within 5-7days after the start of administration
24-hour NIHSS score change
Measured: 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)
Measured: within 24 hours after the start of administration
7 day NIHSS score change
Measured: within 7days after the start of administration
7 day good response rate (NIHSS score reduction greater than 8 points, or NIHSS score 0-1)
Measured: within 7days 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.
- First posted7 Jun 2024
- Study start6 Aug 2024
- Primary completion18 Mar 2025
- Study completion11 Jun 2025
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized, double-blind and double simulated, placebo controlled, single dose escalation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447415
- Sponsor's protocol ID
- HRS-7450-102
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06447415
- Acronym / sponsor ID
- HRS-7450-102
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 7 Jun 2024 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, randomized, double-blind and double simulated, placebo controlled, single dose escalation
| Arm | Type | Receives |
|---|---|---|
| HRS-7450 | Experimental | Drug: HRS-7450 |
| 0.9% sodium chloride injection | Placebo comparator | Drug: 0.9% sodium chloride injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
- 18 ≤ Age ≤ 80 years old;
- 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);
- Clinically diagnosed as acute ischemic stroke (diagnosis follows the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023);
- mRS score ≤ 2 before the first episode;
Key exclusion criteria (32 listed)
- Treatment with ateplase, teneplase, or other thrombolytic drugs;
- Proposed endovascular treatment;
- Intracranial hemorrhagic diseases;
- Aortic arch dissection;
- NIHSS awareness score 1a>2 points;
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-7450HRS-7450 Injection | Drug | HRS-7450 |
| 0.9% sodium chloride injection0.9% sodium chloride injection | Drug | 0.9% sodium chloride injection |
Primary outcome
Symptomatic Intracranial Hemorrhage within 36 hours after the start of administration, The incidence of sICH
Time frame: within 36 hours after the start of administration
11 secondary outcomes
7 day mortality rate after administration
Time frame: within 7days after the start of administration
The incidence of sICH 7 days after administration
Time frame: within 7days after the start of administration
The incidence of ICH 7 days after administration
Time frame: within 7days after the start of administration
The incidence of systemic bleeding 7 days after administration
Time frame: within 7days after the start of administration
Effective reperfusion rate measured by 24-hour PWI or CTP
Time frame: within 24 hours after the start of administration
24-hour MRA or CTA measurement of vascular reperfusion rate
Time frame: within 24 hours after the start of administration
Infarct core volume measured by CT or MRI at 5-7 days
Time frame: within 5-7days after the start of administration
24-hour NIHSS score change
Time frame: 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)
Time frame: within 24 hours after the start of administration
7 day NIHSS score change
Time frame: within 7days after the start of administration
7 day good response rate (NIHSS score reduction greater than 8 points, or NIHSS score 0-1)
Time frame: within 7days 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 29 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-7450 and 0.9% sodium chloride injection in people with Acute Ischemic Stroke, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site 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 7 inclusion and 32 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Symptomatic Intracranial Hemorrhage within 36 hours after the start of administration, The incidence of sICH (time frame: within 36 hours 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?
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 29 Sep 2025.