The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).

Eligibility criteria

Qualifiers

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);

Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.

Clinical diagnosis of acute ischemic stroke (AIS).

Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.

Disqualifiers

Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.;

Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2;

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.

Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment;

Trial design

Treatments tested in this trial

  • HRS-4029
  • Placebo

Treatment groups

340 Participants
are divided into 4 treatment groups