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> Record changed: 2026-10-13

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

NCT07241520

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

Participants

1,096

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

Lead sponsor

Shanghai Hutchison Pharmaceuticals Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

Start date

2025-12-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Title and summary

**Summary**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Acronym**

SAIL

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Official title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Dates

**Completion date**

2027-11-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**First posted**

2025-11-21

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Registry last updated**

2026-01-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Primary completion date**

2027-06-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Start date**

2025-12-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Size and sites

**Participants**

1,096

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Planned participants**

1,096

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Randomisation ratio**

1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Lead sponsor**

Shanghai Hutchison Pharmaceuticals Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Identifiers

**Registry ID**

NCT07241520

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**ClinicalTrials.gov ID**

NCT07241520

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masking description**

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.

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Outcomes

### Primary outcomes

1. Modified Rankin Scale (mRS), with scores of 0-1 at Day 90  
Timeframe: 90±7 days  
Proportion of participants with mRS scores of 0-1 at Day 90

### Secondary outcomes

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

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Sites

- Linfen Central HospitalLinfen, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241520)

## Related records

### Drugs (1)

- [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md)

### Collaborators (1)

- Beijing Tiantan Hospital

### Lead sponsors (1)

- [Shanghai Hutchison Pharmaceuticals Limited](https://trialight.com/data/company/shanghai-hutchison-pharmaceuticals-limited-519ca25e-b124-421c-ba72-508180e17d4a.md)

### Conditions (2)

- [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md)
- [Transient ischemic attack](https://trialight.com/data/condition/transient-ischemic-attack-4355dfad-752a-55bb-8d3e-cd43c9c8144b.md) Primary condition

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