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Recruiting Phase 2 NCT06322394

BXOS110 Injection in the Treatment of Acute Ischaemic Stroke

Trial Parameters

Condition Acute Ischemic Stroke
Sponsor Biocells (Beijing) Biotech Co.,Ltd
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2024-02-07
Completion 2025-03
Interventions
high-dose BXOS110low-dose BXOS110Placebo

Brief Summary

The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke.

Eligibility Criteria

Inclusion Criteria: 1. Age18\~85 (including 18 and 85 years),no gender limitation; 2. Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition); 3. 6 ≤ NIHSS score ≤ 20 before randomisation; 4. Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time); 5. First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1); 6. Subjects who are able to understand and comply with the study procedures, and who agree to sign the study informed consent form in writing to indicate that they are willing to participate in the trial (the informed consent form can be signed by subjects or their legal representatives). Exclusion Criteria: 1.

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