NCT07396337 Study to Assess the Efficacy and Safety of QHRD106 Injection in Acute Ischemic Stroke.
| NCT ID | NCT07396337 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Changzhou Qianhong Bio-pharma Co., Ltd. |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2026-01-19 |
| Primary Completion | 2026-10-31 |
Trial Parameters
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Brief Summary
The purpose of this study is to determine the efficacy and safety of QHRD106 injection in treating acute ischemic stroke.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 80 years old; 2. Patients diagnosed as acute ischemic stroke according to the latest guidelines； 3. Patients who have not received or have no plan to receive standard intravenous thrombolysis within 24 hours after the onset of the disease and can complete the first administration of the investigational drug within 24 hours after the onset.； 4. Total National Institute of Health stroke scale (NIHSS)≥6 and ≤20, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2； 5. The mRS score before the onset of the disease is ≤ 1 point; 6. Obtain the informed consent form signed by the patient or their guardian. Exclusion Criteria: 1. Combine intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc； 2. Individuals with any of the following allergy histories must be excluded: 1) Those who are allergic to the t
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