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

NCT06202378 | Completed Phase 2 FDA Drug

• 1 other identifier: SHPL-Z003-201
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 16

Brief Summary

This study is designed to determine the safety and efficacy of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects.

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 (19)

• Shift analysis/ Ordinal analysis

  90±7 days

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

  30±3 days

• Modified Rankin Scale (mRS), with scores of 0-2 at Day 30

  30±3 days

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

  90±7 days

• National Institute of Health stroke scale (NIHSS) on day 7or 8

  7 days or 8 days

Study Arms (3)

SHPL-49 Injection，3 ampoules

EXPERIMENTAL

1mL/ampoule

Drug: 3 ampoules of SHPL-49 Injection

SHPL-49 Injection，6 ampoules

EXPERIMENTAL

1mL/ampoule

Drug: 6 ampoules of SHPL-49 Injection

Placebo

PLACEBO COMPARATOR

1mL/ampoule

Drug: 0.9% Sodium Chloride Injection

Interventions

3 ampoules of SHPL-49 Injection DRUG

3 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，3 ampoules

6 ampoules of SHPL-49 Injection DRUG

6 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，6 ampoules

0.9% Sodium Chloride Injection DRUG

100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

Placebo

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 with acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this research center) within 8h after the onset of the disease;
• Participants who have NIHSS ≥5 and ≤ 22 before thrombolysis;
• Pre-stroke mRS Score ≤1;
• Participants 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 (ASPECT score \< 6 or 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 receive intravascular therapy;
• After the onset of the disease, drugs with neuroprotective effects have been applied in the instructions. Such as commercially available Edaravone, Edaravone and Dexborneol Concentrated Solution for Injection, Butylphthalide, Nimodipine, Ganglioside, Citicoline, Piracetam, Oxiracetam, Human Urinary Kallidinogenase, Cinepazide, Mouse Nerve Growth Factor For Injection, Cerebrolysin, Deproteinised Calf Blood Serum Injection, Deproteinised Calf Blood Extractives Injection, etc.;
• Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after taking antihypertensive drugs before thrombolysis;
• Severe renal insufficiency: serum creatinine \>2 times the upper limit of normal or creatinine clearance (CLcr)\< 30mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency; (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 liver function impairment: Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)\>3 times the upper limit of normal, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, 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 concurrent malignant tumors or undergoing anti-tumor therapy;
• Allergic to experimental drugs or similar ingredients or materials used in imaging examinations;
• Patients during pregnancy, breastfeeding 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;
• Suspected or confirmed 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);

Sponsors & Collaborators

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

Study Sites (16)

Beijing Tiantan Hosptial，Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Yuebei People's Hospital

Shaoguan, Guangdong, 512026, China

Location

Hengshui People's Hospital

Hengshui, Hebei, 053099, China

Location

Tangshan Workers' Hospital

Tangshan, Hebei, 063099, China

Location

Nanshi Hospital of Nanyang

Nanyang, Henan, 473010, China

Location

General Hospital of Pingmei Shenma Group

Pingdingshan, Henan, 467099, China

Location

Keshiketeng Banner Traditional Chinese Medicine and Mongolian Medicine Hospital

Chifeng, Inner Mongolia, 025350, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Beipiao Central Hospital

Beipiao, Liaoning, 122199, China

Location

Shenyang Medical College Affiliated Central Hospital

Shenyang, Liaoning, 110024, China

Location

The First People's Hospital of Shenyang

Shenyang, Liaoning, 110041, China

Location

Linyi People's Hospital

Linyi, Shandong, 276100, China

Location

The First People's Hospital of Tancheng

Linyi, Shandong, 276100, China

Location

Sinopharm Tongmei General Hospital

Datong, Shanxi, 037001, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041000, China

Location

Linfen People's Hospital

Linfen, Shanxi, 041000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yongjun Wang, master

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 11, 2024
• Study Start: December 29, 2023
• Primary Completion: November 26, 2024
• Study Completion: December 16, 2024
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

CN (16)