SHPL-49 injection for treating acute ischemic stroke (Phase III)

Phase III Clinical Trial to Evaluate the Efficacy and Safety of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke（SAIL）- a Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial

This trial tests whether a seven-day course of intravenous SHPL-49 helps adults with acute ischemic stroke who receive thrombolysis within eight hours of symptom onset.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1096 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Hutchison Pharmaceuticals Limited (Industry-sponsored)
• Locations: 1 site (Linfen, Shanxi)
• Trial ID: NCT07241520 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase III trial comparing SHPL-49 injection to placebo in patients with acute ischemic stroke who receive or plan to receive standard intravenous thrombolysis within eight hours of symptom onset. About 1,096 participants will be randomized 1:1 and receive a total of 14 intravenous doses delivered primarily as twice-daily dosing over the treatment period. Key eligibility includes age 18–80, baseline NIHSS 5–22, and pre-stroke mRS ≤1, while patients with intracranial hemorrhage, large anterior-circulation infarcts, or severe impaired consciousness are excluded. The trial aims to measure safety and whether SHPL-49 improves neurological and functional outcomes compared with placebo.

Who should consider this trial

Good fit: Adults 18–80 with acute ischemic stroke who receive or plan to receive standard IV thrombolysis within eight hours of symptom onset, with NIHSS 5–22 and pre-stroke mRS ≤1, are ideal candidates.

Not a fit: Patients with hemorrhagic stroke, large anterior-circulation infarcts, severe disturbances of consciousness, or those presenting outside the 8-hour window are unlikely to be eligible or to receive benefit.

Why it matters

Potential benefit: If successful, SHPL-49 could improve neurological recovery and functional outcomes when given soon after an ischemic stroke treated with thrombolysis.

How similar studies have performed: Neuroprotective approaches given around reperfusion have had mixed results historically, so SHPL-49's efficacy in a large Phase III trial is currently unproven.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old (including upper and lower limits);
2. Clinically diagnosed as acute ischemic stroke according to the latest guidelines;
3. Patients diagnosed as acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this research center) within 8hours of symptom onset;
4. Patients who have NIHSS score≥5 and ≤ 22 before thrombolysis;
5. Pre-stroke mRS score ≤1;
6. Patients or legally authorized representatives who are able and willing to sign informed consent.

Exclusion Criteria:

1. Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
2. Severe disturbance of consciousness: patients with NIHSS 1a consciousness level item score ≥2;
3. Cerebral Computed tomography (CT) or Magnetic resonance imaging (MRI) indicated a large anterior circulation cerebral infarction (infarct area greater than 1/3 of the middle cerebral artery blood supply area);
4. Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes;
5. Patients who are ready to receive or have received endovascular therapy;
6. After the onset of the disease, the drugs with neuroprotective effects which have been used: commercially available Edaravone, Edaravone and Dexborneol, Butylphthalide, Citicoline, Nimodipine, Ganglioside, Human Urinary Kallidinogenase, Cinepazide, Cattle Encephalon Glycoside and Ignotin, Fasudil, Compound Porcine Cerebroside and Ganglioside, Piracetam, Oxiracetam, Mouse Nerve Growth Factor For Injection, Cerebrolysin, Deproteinised Calf Blood Serum Injection, Deproteinised Calf Blood Extractives Injection, Ginkgolides Injection, Ginkgolides Diterpene Lactone Meglumine Injection, Ginkgo Leaf Extract and Dipyridamole Injection, Extract of Ginkgo Biloba Leaves Injection, Safflower Extract and Aceglutamide Injection, Xuesaitong Injection, Xuesaitong Soft Capsules, and injections containing any single eXtract of Chuanxiong (Chuanxiong Rhizoma), Danshen (Salviae Miltiorrhizae Radix ET Rhizoma), Hongjingtian (Rhodiolae Crenulatae Radix Et Rhizoma),or several of these Chinese herbal ingredients;
7. Patients with a history of atrial fibrillation, deep vein thrombosis of the lower extremities, pulmonary embolism or other conditions that require the use of anticoagulant drugs during administration;
8. Severe hypertension: systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg after taking antihypertensive drugs before thrombolysis;
9. Severe renal insufficiency: serum creatinine \>2 times upper limit of normal or creatinine clearance (CLcr) \< 30mL/min (Cockcroft-Gault formula), or with other known severe renal insufficiency such as renal failure and uremia ; (Note: Cockcroft Gault formula: (1) Male: CLcr (mL/min) = \[140 - age (yrs)\]× body weight (kg) / \[0.814 × serum creatinine (μmol/L)\]; (2) female: CLcr (mL/min) = {\[140 - age (years old)\] by weight (kg) / \[0.814 x serum creatinine (μmol/L)\]} x 0.85);
10. Severe hepatic function impairment: Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST) 3 times upper limit of normal, or with other known hepatic diseases such as hepatic failure, hepatic cirrhosis, portal hypertension (with esophageal varices), active hepatitis, etc.;
11. Patients with a heart function rating above Class II (according to the New York Heart Association (NYHA) heart function rating) or a history of congestive heart failure;
12. Patients with malignant tumors or undergoing anti-tumor therapy;
13. Allergic to experimental drugs or similar ingredients or materials used in imaging examinations;
14. Patients during pregnancy, lactation or planning pregnancy;
15. Patients who have a history of epilepsy or have had seizure-like symptoms at the onset of stroke, or suffer from serious mental disorders, intellectual disabilities or dementia;
16. Alcohol dependence, or drinking more than 3 units (male) or 2 units (female) of alcohol within 24 hours prior to onset (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
17. Patients have participated in other drug or non-drug clinical studies, or are participating in another clinical study within 3 months before signing informed consent form;
18. Patients have a history of severe head trauma or stroke within the past 3 months;
19. Patients are suffering from severe systemic diseases, with a life expectancy of less than 90 days;
20. Patients who are judged unsuitable for participation by the investigators in the study.

Where this trial is running

Linfen, Shanxi

• Linfen Central Hospital — Linfen, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Yongjun Wang, Master — Beijing Tiantan Hospital
• Study coordinator: Wenwen Xu, Master

Conditions Acute Ischemic Stroke