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Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke

Testing SHPL-49 Injection for safety and effectiveness in stroke patients.

Recruiting
18-80 years
All
Phase 2
This study investigates the **safety** and **effectiveness** of a new treatment called **SHPL-49** for people who have experienced an **acute ischemic stroke**. An acute ischemic stroke happens when a blood clot blocks blood flow to the brain, causing brain cells to die. The treatment involves an **intravenous infusion** (a way to give medicine directly into the vein) given for seven days. The study aims to find out how well different doses of SHPL-49 work and if they are safe to use. The trial is a **Phase II** study, meaning it is in the early stages of testing. It uses a **randomized, double-blind, placebo-controlled** design, which means participants are randomly assigned to receive the treatment or a placebo without knowing which one they are getting. The trial involves 270 participants who will be divided into groups receiving different doses. **Key Points:** - The study lasts for 7 days with a total of 14 doses. - Participants must be aged 18-80 and have had a stroke within 8 hours. - **Exclusion** criteria include severe liver or kidney issues, certain heart conditions, and recent participation in other studies. Participants will help researchers understand more about the potential benefits and risks of SHPL-49 treatment.
Study details
    Acute Ischemic Stroke

NCT06202378

Shanghai Hutchison Pharmaceuticals Limited

24 January 2024

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