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> Record changed: 2026-10-13

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

NCT06202378

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

Participants

270

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

Lead sponsor

Shanghai Hutchison Pharmaceuticals Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

Start date

2023-12-29

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

Number of sites

16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Official title**

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Dates

**Completion date**

2024-12-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**First posted**

2024-01-11

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Registry last updated**

2025-10-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Primary completion date**

2024-11-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Start date**

2023-12-29

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Size and sites

**Actual participants**

270

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Participants**

270

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Randomisation ratio**

1:1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Number of sites**

16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Lead sponsor**

Shanghai Hutchison Pharmaceuticals Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Identifiers

**Registry ID**

NCT06202378

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**ClinicalTrials.gov ID**

NCT06202378

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## 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. Shift analysis/ Ordinal analysis  
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 0-1 at Day 30  
Timeframe: 30±3 days  
Proportion of participants with mRS Scores of 0-1 at Day 30
3. Modified Rankin Scale (mRS), with scores of 0-2 at Day 30  
Timeframe: 30±3 days  
Proportion of participants with mRS Scores of 0-2 at Day 30
4. 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
5. National Institute of Health stroke scale (NIHSS) on day 7or 8  
Timeframe: 7 days or 8 days  
The proportion of participants with NIHSS scores of 0-1 or with ≥4 point reduction from baseline on day 7 or 8 (after the completion of the final dose)
6. National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge  
Timeframe: 14±2 days  
The proportion of participants with NIHSS scores of 0 to 1 or with 4 points reduction from baseline on day 14 or at discharge
7. Barthel index (BI) at Day 30  
Timeframe: 30±3 days  
Proportion of participants with Barthel index ≥95 at Day 30
8. Barthel inde (BI) at Day 90  
Timeframe: 90±7 days  
Proportion of participants with BI ≥95 at Day 90
9. National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge  
Timeframe: 14±2 days or at discharge  
Changes in NIHSS scores from baseline at Day 14 or at discharge
10. Symptomatic intracranial hemorrhage  
Timeframe: 22-36h after thrombolysis  
Symptomatic intracranial hemorrhage within 36h after thrombolysis (Safe Implementation of Thrombolysis in Stroke-Monitoring Study Criteria)
11. Mortality  
Timeframe: 90±7 days  
Mortality over the 90-day study period
12. Serious adverse events  
Timeframe: 90±7 days  
Serious adverse events over the 90-day study period
13. Adverse events  
Timeframe: 90±7 days  
Adverse events over the 90-day study period
14. Changes in laboratory test indicators  
Timeframe: 7 days or 8 days，14±2 days，90±7 days  
Changes in laboratory test indicators on day 7 or 8(at the end of the last dose), at Day 14 or at discharge, and at Day 90
15. Changes in vital signs before and after administration  
Timeframe: 7 days or 8 days，14±2 days，90±7 days  
Changes in vital signs on day 7 or 8 (at the end of the last dose), at Day14 or at discharge , and at Day 90
16. 12-lead electrocardiogram  
Timeframe: 90±7 days  
Abnormal 12-lead electrocardiogram over the 90-day study period
17. Vital signs  
Timeframe: 90±7 days  
Abnormal vital signs over the 90-day study period
18. Physical examination  
Timeframe: 90±7 days  
Abnormal results of physical examination over the 90-day study period
19. Laboratory test indicators  
Timeframe: 90±7 days  
Abnormal laboratory test indicators over the 90-day study period

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## 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 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;
4. Participants who have NIHSS ≥5 and ≤ 22 before thrombolysis;
5. Pre-stroke mRS Score ≤1;
6. Participants 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 (ASPECT score < 6 or 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 receive intravascular therapy;
6. 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.;
7. Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after taking antihypertensive drugs before thrombolysis;
8. 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)
9. 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.;
10. 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;
11. Patients with concurrent malignant tumors or undergoing anti-tumor therapy;
12. Allergic to experimental drugs or similar ingredients or materials used in imaging examinations;
13. Patients during pregnancy, breastfeeding or planning pregnancy;
14. 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;
15. 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);
16. Patients have participated in or are participating in another clinical study within the 3 months before singing informed consent;
17. Patients who are judged unsuitable for participation by the investigators in the study.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## Sites

- Beijing Tiantan Hosptial，Capital Medical UniversityBeijing, China
- Yuebei People's HospitalShaoguan, China
- Hengshui People's HospitalHengshui, China
- Tangshan Workers' HospitalTangshan, China
- Nanshi Hospital of NanyangNanyang, China
- General Hospital of Pingmei Shenma GroupPingdingshan, China
- Keshiketeng Banner Traditional Chinese Medicine and Mongolian Medicine HospitalChifeng, China
- The First Hospital of Jilin UniversityChangchun, China
- Beipiao Central HospitalBeipiao, China
- Shenyang Medical College Affiliated Central HospitalShenyang, China
- The First People's Hospital of ShenyangShenyang, China
- Linyi People's HospitalLinyi, China
- The First People's Hospital of TanchengLinyi, China
- Sinopharm Tongmei General HospitalDatong, China
- Linfen Central HospitalLinfen, China
- Linfen People's HospitalLinfen, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06202378)

## 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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