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

NCT07241520 | Recruiting Phase 3 DMC

• 1 other identifier: SHPL-Z003-301
• Study Type: interventional
• Target: 1,096
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Modified Rankin Scale (mRS), with scores at Day 90

  90±7 days

• Modified Rankin Scale (mRS), with scores of 0-2 at Day 90

  90±7 days

• Barthel index (BI) at Day 90

  90±7 days

• Modified Rankin Scale (mRS), with scores of 0-1 at Day 30

  30±3 days

• National Institute of Health stroke scale (NIHSS), with scores of 0-1 at Day 7 or 8

  7 days or 8 days

Study Arms (2)

SHPL-49 Injection

EXPERIMENTAL

3mL/ ampoule

Drug: SHPL-49 Injection

Placebo Injection

PLACEBO COMPARATOR

3mL/ ampoule

Drug: Placebo Injection

Interventions

SHPL-49 Injection DRUG

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.

SHPL-49 Injection

Placebo Injection DRUG

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.

Placebo Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old (including upper and lower limits);
• Clinically diagnosed as acute ischemic stroke according to the latest guidelines;
• 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;
• Patients who have NIHSS score≥5 and ≤ 22 before thrombolysis;
• Pre-stroke mRS score ≤1;
• Patients or legally authorized representatives who are able and willing to sign informed consent.

You may not qualify if:

• Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
• Severe disturbance of consciousness: patients with NIHSS 1a consciousness level item score ≥2;
• 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);
• Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes;
• Patients who are ready to receive or have received endovascular therapy;
• 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;
• 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;
• Severe hypertension: systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg after taking antihypertensive drugs before thrombolysis;
• 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);
• 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.;
• 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;
• Patients with malignant tumors or undergoing anti-tumor therapy;
• Allergic to experimental drugs or similar ingredients or materials used in imaging examinations;
• Patients during pregnancy, lactation or planning pregnancy;
• 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;

Sponsors & Collaborators

• Shanghai Hutchison Pharmaceuticals Limited: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Linfen Central Hospital

Linfen, Shanxi, 041000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, Master

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenwen Xu, Master

CONTACT

86-21-62506452; xuwenwen@shpl.com.cn

Xiaoling Zhao, Master

CONTACT

86-21-62506452; zhaoxiaoling@shpl.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind study, the participant, and all relevant personnel involved with the conduct and interpretation of the study (including investigator, investigational site personnel, and the sponsor or designee's staff) will remain blinded to the identity of the Investigational Product (IP) assigned and the randomization codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)