Acute Ischemic StrokePhase 3SAILNCT07241520
Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke
A Phase 3 study testing SHPL-49 Injection in people with Acute Ischemic Stroke, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.
Trial summary
This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- SHPL-49 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,096 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 30 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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);
- 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;
- Patients have a history of severe head trauma or stroke within the past 3 months;
- Patients are suffering from severe systemic diseases, with a life expectancy of less than 90 days;
- Patients who are judged unsuitable for participation by the investigators in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 041000
Hongguo Dai, Master, 86-15935767592, daihongguo3199@163.com
About this study
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
This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- SHPL-49 Injection, Placebo Injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHPL-49 InjectionDrug
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 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SHPL-49 Injection | Experimental | 3mL/ ampoule Receives: Drug: SHPL-49 Injection |
| Placebo Injection | Placebo comparator | 3mL/ ampoule Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
Proportion of participants with mRS scores of 0-1 at Day 90
Measured: 90±7 days
Secondary outcomes (10)
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
Measured: 90±7 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
Measured: 90±7 days
Barthel index (BI) at Day 90
Proportion of participants with BI ≥95 at Day 90
Measured: 90±7 days
Modified Rankin Scale (mRS), with scores of 0-1 at Day 30
Proportion of participants with mRS Scores of 0-1 at Day 30
Measured: 30±3 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)
Measured: 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)
Measured: 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)
Measured: 22-36hours after thrombolysis
Mortality
Mortality over the 90-day study period
Measured: 90±7 days
Serious adverse events
Serious adverse events over the 90-day study period
Measured: 90±7 days
Adverse events
Adverse events over the 90-day study period
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start8 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,096 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, Master, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241520
- Sponsor's protocol ID
- SHPL-Z003-301
- Acronym
- SAIL
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07241520
- Acronym / sponsor ID
- SAIL / SHPL-Z003-301
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,096 participants (estimated)
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHPL-49 Injection | Experimental | Drug: SHPL-49 Injection3mL/ ampoule |
| Placebo Injection | Placebo comparator | Drug: Placebo Injection3mL/ ampoule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHPL-49 Injection2 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. | Drug | SHPL-49 Injection |
| Placebo Injection2 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. | Drug | Placebo Injection |
Primary outcome
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
Time frame: 90±7 days
Proportion of participants with mRS scores of 0-1 at Day 90
10 secondary outcomes
Modified Rankin Scale (mRS), with scores at Day 90
Time frame: 90±7 days
Modified Rankin Scale (mRS), with scores of 0-2 at Day 90
Time frame: 90±7 days
Barthel index (BI) at Day 90
Time frame: 90±7 days
Modified Rankin Scale (mRS), with scores of 0-1 at Day 30
Time frame: 30±3 days
National Institute of Health stroke scale (NIHSS), with scores of 0-1 at Day 7 or 8
Time frame: 7 days or 8 days
National Institute of Health stroke scale (NIHSS) at Day 7or 8
Time frame: 7 days or 8 days
Symptomatic intracranial hemorrhage
Time frame: 22-36hours after thrombolysis
Mortality
Time frame: 90±7 days
Serious adverse events
Time frame: 90±7 days
Adverse events
Time frame: 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongjun Wang, Master principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHPL-49 Injection in people with Acute Ischemic Stroke, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenwen Xu, Master (86-21-62506452, xuwenwen@shpl.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90 (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.