Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke (SAIL)

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 study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: SHPL-49 Injection; Drug: Placebo Injection

Detailed Description

The objective of this study is to determine the efficacy and safety of SHPL-49 intravenous infusion for 7 consecutive days in acute ischemic stroke patients within 8hours after onset. This study is a Phase III, multicenter, randomized, double-blind, placebo-controlled parallel design. Participants receive twice daily dosing for 7 consecutive days, or once on Day 1 and Day 8 and twice daily on Days 2 to 7, with each participant scheduled to receive 14 doses throughout the clinical trial. 1096 participants will be randomized 1:1 to SHPL-49 injection treated group and placebo group.

• Study Type: Interventional
• Enrollment (Estimated): 1096
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wenwen Xu, Master; Phone Number: 86-21-62506452; Email: xuwenwen@shpl.com.cn
• Study Contact Backup: Name: Xiaoling Zhao, Master; Phone Number: 86-21-62506452; Email: zhaoxiaoling@shpl.com.cn

Study Locations

• China
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Recruiting
      • Linfen Central Hospital
      • Contact: Hongguo Dai, Master; Phone Number: 86-15935767592; Email: daihongguo3199@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHPL-49 Injection; 3mL/ ampoule	Drug: SHPL-49 Injection; 2 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.
Placebo Comparator: Placebo Injection; 3mL/ ampoule	Drug: Placebo Injection; 2 ampoules of Placebo Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90	Proportion of participants with mRS scores of 0-1 at Day 90	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS), with scores of 0-1 at Day 30	Proportion of participants with mRS Scores of 0-1 at Day 30	30±3 days
Modified Rankin Scale (mRS), with scores of 0-2 at Day 90	Proportion of participants with mRS Scores of 0-2 at Day 90	90±7 days
Mortality	Mortality over the 90-day study period	90±7 days
Serious adverse events	Serious adverse events over the 90-day study period	90±7 days
Adverse events	Adverse events over the 90-day study period	90±7 days
Modified Rankin Scale (mRS), with scores at Day 90	A shift of one or more categories to reduced functional dependence analyzed across the whole distribution of outcomes on the mRS at Day 90	90±7 days
Barthel index (BI) at Day 90	Proportion of participants with BI ≥95 at Day 90	90±7 days
National Institute of Health stroke scale (NIHSS), with scores of 0-1 at Day 7 or 8	The proportion of participants with NIHSS scores of 0-1 at day 7 or 8 (at the end of the last dose)	7 days or 8 days
National Institute of Health stroke scale (NIHSS) at Day 7or 8	Changes in NIHSS scores from baseline at Day 7or 8 (at the end of the last dose)	7 days or 8 days
Symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage within 36 hours after thrombolysis as defined by the SITS-MOST Criteria (Safe Implementation of Thrombolysis in Stroke Monitoring Study)	22-36hours after thrombolysis

Collaborators and Investigators

• Sponsor: Shanghai Hutchison Pharmaceuticals Limited
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yongjun Wang, Master, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: SHPL-Z003-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No