Acute Ischemic StrokePhase 2NCT06202378

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

A Phase 2 study testing 3 ampoules of SHPL-49 Injection, 6 ampoules of SHPL-49 Injection and 0.9% Sodium Chloride Injection in people with Acute Ischemic Stroke, run by Shanghai Hutchison Pharmaceuticals Limited at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. 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?: 3 ampoules of SHPL-49 Injection, 6 ampoules of SHPL-49 Injection and 0.9% Sodium Chloride Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 270 participants
Where: 16 sitesChina
Study dates: 29 Dec 2023to 16 Dec 2024
Phase: Phase 2
Are there results?: None posted in the registry

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 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.

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 (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.;

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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);
Patients have participated in or are participating in another clinical study within the 3 months before singing informed consent;
Patients who are judged unsuitable for participation by the investigators in the study.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

China16 sites

Beijing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, 100070
Beipiao Central Hospital
Beipiao, Liaoning, 122199
The First Hospital of Jilin University
Changchun, Jilin, 130021
Keshiketeng Banner Traditional Chinese Medicine and Mongolian Medicine Hospital
Chifeng, Inner Mongolia, 025350
Sinopharm Tongmei General Hospital
Datong, Shanxi, 037001
Hengshui People's Hospital
Hengshui, Hebei, 053099
Linfen Central Hospital
Linfen, Shanxi, 041000
Linfen People's Hospital
Linfen, Shanxi, 041000
Linyi People's Hospital
Linyi, Shandong, 276100
The First People's Hospital of Tancheng
Linyi, Shandong, 276100
Nanshi Hospital of Nanyang
Nanyang, Henan, 473010
General Hospital of Pingmei Shenma Group
Pingdingshan, Henan, 467099
Yuebei People's Hospital
Shaoguan, Guangdong, 512026
Shenyang Medical College Affiliated Central Hospital
Shenyang, Liaoning, 110024
The First People's Hospital of Shenyang
Shenyang, Liaoning, 110041
Tangshan Workers' Hospital
Tangshan, Hebei, 063099

Other trials in China

About this study

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

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.

Read the detailed description

Trial Objectives:

The primary objective of this study is to determine the effectiveness of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset.

The secondary objective is to determine the safety of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset.

Trial Design:

This study is a Phase II, multicenter, randomized, double Blind, placebo-Controlled design. Participants receive twice daily dosing for 7 consecutive days, or once on Days 1 and Day 8 and twice daily on Days 2 to Day 7, with each subject scheduled to receive 14 doses throughout the clinical trial. 270 Participants will be randomized 1:1:1 to SHPL-49 injection treated group (3 ampoules of SHPL-49 injections, Bis in die（BID）), SHPL-49 injection treated group (6 ampoules of SHPL-49 injections , BID) and placebo group (BID).

Conditions: Acute Ischemic Stroke
Being tested: 3 ampoules of SHPL-49 Injection, 6 ampoules of SHPL-49 Injection, 0.9% Sodium Chloride 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.

3 ampoules of SHPL-49 InjectionDrug
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.
6 ampoules of SHPL-49 InjectionDrug
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.
0.9% Sodium Chloride InjectionDrug
100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

Study groups in NCT06202378
Study group	Role	What they receive
SHPL-49 Injection，3 ampoules	Experimental	1mL/ampoule Receives: Drug: 3 ampoules of SHPL-49 Injection
SHPL-49 Injection，6 ampoules	Experimental	1mL/ampoule Receives: Drug: 6 ampoules of SHPL-49 Injection
Placebo	Placebo comparator	1mL/ampoule Receives: Drug: 0.9% Sodium Chloride 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 (19)

Shift analysis/ Ordinal analysis
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 0-1 at Day 30
Proportion of participants with mRS Scores of 0-1 at Day 30
Measured: 30±3 days
Modified Rankin Scale (mRS), with scores of 0-2 at Day 30
Proportion of participants with mRS Scores of 0-2 at Day 30
Measured: 30±3 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
National Institute of Health stroke scale (NIHSS) on day 7or 8
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)
Measured: 7 days or 8 days
National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge
The proportion of participants with NIHSS scores of 0 to 1 or with 4 points reduction from baseline on day 14 or at discharge
Measured: 14±2 days
Barthel index (BI) at Day 30
Proportion of participants with Barthel index ≥95 at Day 30
Measured: 30±3 days
Barthel inde (BI) at Day 90
Proportion of participants with BI ≥95 at Day 90
Measured: 90±7 days
National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge
Changes in NIHSS scores from baseline at Day 14 or at discharge
Measured: 14±2 days or at discharge
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 36h after thrombolysis (Safe Implementation of Thrombolysis in Stroke-Monitoring Study Criteria)
Measured: 22-36h 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
Changes in laboratory test indicators
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
Measured: 7 days or 8 days，14±2 days，90±7 days
Changes in vital signs before and after administration
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
Measured: 7 days or 8 days，14±2 days，90±7 days
12-lead electrocardiogram
Abnormal 12-lead electrocardiogram over the 90-day study period
Measured: 90±7 days
Vital signs
Abnormal vital signs over the 90-day study period
Measured: 90±7 days
Physical examination
Abnormal results of physical examination over the 90-day study period
Measured: 90±7 days
Laboratory test indicators
Abnormal laboratory test indicators 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.

29 Dec 202316 Dec 2024

First posted11 Jan 2024
Study start29 Dec 2023
Primary completion26 Nov 2024
Study completion16 Dec 2024

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06202378
Sponsor's protocol ID: SHPL-Z003-201
Status last verified: Oct 2025
First submitted: 28 Dec 2023
Last updated: 28 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06202378
Acronym / sponsor ID: SHPL-Z003-201
Conditions: Acute Ischemic Stroke
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Shanghai Hutchison Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
Collaborators: Beijing Tiantan Hospital
Study start: 29 Dec 2023 (actual)
Primary completion: 26 Nov 2024 (actual)
Study completion: 16 Dec 2024 (actual)
First posted: 11 Jan 2024 (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 safety and efficacy of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects.

Detailed description

Trial Objectives:

The secondary objective is to determine the safety of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset.

Trial Design:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SHPL-49 Injection，3 ampoules	Experimental	Drug: 3 ampoules of SHPL-49 Injection1mL/ampoule
SHPL-49 Injection，6 ampoules	Experimental	Drug: 6 ampoules of SHPL-49 Injection1mL/ampoule
Placebo	Placebo comparator	Drug: 0.9% Sodium Chloride Injection1mL/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 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;

Key exclusion criteria (17 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 (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;

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
3 ampoules of SHPL-49 Injection3 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，3 ampoules
6 ampoules of SHPL-49 Injection6 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，6 ampoules
0.9% Sodium Chloride Injection100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.	Drug	Placebo

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

19 secondary outcomes

Shift analysis/ Ordinal analysis
Time frame: 90±7 days
Modified Rankin Scale (mRS), with scores of 0-1 at Day 30
Time frame: 30±3 days
Modified Rankin Scale (mRS), with scores of 0-2 at Day 30
Time frame: 30±3 days
Modified Rankin Scale (mRS), with scores of 0-2 at Day 90
Time frame: 90±7 days
National Institute of Health stroke scale (NIHSS) on day 7or 8
Time frame: 7 days or 8 days
National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge
Time frame: 14±2 days
Barthel index (BI) at Day 30
Time frame: 30±3 days
Barthel inde (BI) at Day 90
Time frame: 90±7 days
National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge
Time frame: 14±2 days or at discharge
Symptomatic intracranial hemorrhage
Time frame: 22-36h after thrombolysis
Mortality
Time frame: 90±7 days
Serious adverse events
Time frame: 90±7 days
Adverse events
Time frame: 90±7 days
Changes in laboratory test indicators
Time frame: 7 days or 8 days，14±2 days，90±7 days
Changes in vital signs before and after administration
Time frame: 7 days or 8 days，14±2 days，90±7 days
12-lead electrocardiogram
Time frame: 90±7 days
Vital signs
Time frame: 90±7 days
Physical examination
Time frame: 90±7 days
Laboratory test indicators
Time frame: 90±7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.

Related trials for Acute Ischemic Stroke

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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. This study is not recruiting at the moment.

Yongjun Wang, master principal investigator

Beijing Tiantan Hospital

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 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: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT06202378.

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 28 Oct 2025.