HRS-4029 for Acute Ischemic Stroke: Is It Safe and Helpful

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study compares HRS-4029 to placebo in adults who recently began an acute ischemic stroke and meet specific neurological criteria. Participants receive the study drug or placebo within 3 hours of stroke onset and are monitored for safety and signs of functional improvement. The trial uses standard stroke scales to measure outcomes and excludes patients with certain brain bleeds or severe impairment. The study is led by Beijing Suncadia Pharmaceuticals with recruitment at Beijing Tiantan Hospital. Enrollment depends on informed consent and eligibility related to stroke timing and severity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative).
2. Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.
3. Clinical diagnosis of acute ischemic stroke (AIS).
4. Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.
5. National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 at screening, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2.

Exclusion Criteria:

1. Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc..
2. Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2.
3. Concurrent other neurological/psychiatric disorders (e.g., Parkinsonism, epilepsy, severe cognitive impairment, severe depression, etc.) that render the patient uncooperative or unwilling to cooperate with physical examination, or that may affect the evaluation of outcomes.
4. Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment.
5. Severe hyperglycemia or hypoglycemia.
6. Any of the following within 3 months prior to enrollment: acute ST-elevation myocardial infarction , and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or hospitalization or unplanned coronary intervention due to acute coronary syndrome, myocardial infarction, or cardiac arrest; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia.
7. History of severe hepatic impairment.
8. History of severe renal insufficiency.
9. Advanced malignancy or currently undergoing antineoplastic treatment.
10. Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening.
11. Participation in another interventional clinical trial involving an investigational drug or medical device (defined as having signed an informed consent form and received the investigational product/device) within 3 months prior to the screening visit.
12. Terminal illness with an estimated life expectancy of less than 1 year.
13. Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Shengjie Zhang, MM
• Email: jiawen.xu.jx130@hengrui.com
• Phone: +86 13612175401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mobilisation After Endovascular Stroke Treatment

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• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.