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Acute Ischemic Stroke AISPhase 2/3NCT07903701

A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke

A Phase 2/3 study testing SIM0811 Dose Level A (Phase II), SIM0811 Dose Level B (Phase II) and SIM0811 Dose Level C (Phase II) in people with Acute Ischemic Stroke AIS, run by Jiangsu Simcere Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study will evaluate the efficacy and safety of SIM0811 in participants with acute ischemic stroke who are present within 4.5 to 24 hours since last known well. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke AIS
What is being tested?
SIM0811 Dose Level A (Phase II), SIM0811 Dose Level B (Phase II) and SIM0811 Dose Level C (Phase II)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,092 participants
Where
No sites listed yet
Study dates
30 Nov 2026to 30 Jun 2029
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Time from last known well: 4.5 to 24 hours.
  • Acute ischemic stroke in a supratentorial territory, with corresponding clinical manifestations, and symptomatic high-grade stenosis or complete occlusion of the culprit vessel, involving the middle cerebral artery (MCA) M1, M2, or distal branches, the anterior cerebral artery (ACA), or the posterior cerebral artery (PCA).
  • NIHSS score of 6-25 for the current stroke.
  • Pre-stroke mRS ≤ 1.
  • Female participants of childbearing potential and male participants whose partners are of childbearing potential must agree to use a highly effective contraceptive method from the time of informed consent signature until 6 months after the last dose of investigational product, and to refrain from donating sperm/ova.
  • A written informed consent form approved by the Ethics Review Committee/Institutional Review Board (IRB), voluntarily signed by the patient or their legally authorized representative

Who cannot join

  • Planned to undergo endovascular treatment or planned to receive thrombolytic drug therapy
  • NIHSS consciousness score 1a > 2
  • .Head, neck, or aortic dissection
  • History of intracranial hemorrhage
  • Ischemic stroke, severe traumatic brain injury, or intracranial/spinal surgery within 3 months; internal bleeding within 3 weeks; major surgical operation or trauma within 2 weeks; arterial puncture at a non-compressible site within the past week; active internal bleeding
  • Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
Show all 21Show fewer
  • Known bleeding tendency (hereditary or acquired) or any severe coagulation disorder. Specifically: platelet count < 100,000/μL, international normalized ratio (INR) > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds
  • Therapeutic-dose heparin or low molecular weight heparin within 24 hours
  • Use of oral anticoagulants within 48 hours, including vitamin K antagonists, thrombin inhibitors, or factor Xa inhibitors, or other investigational anticoagulant drugs
  • Use of platelet glycoprotein IIb/IIIa receptor inhibitors within 48 hours
  • Uncorrected blood glucose level > 22.22 mmol/L or < 2.78 mmol/L during screening (participants whose blood glucose level is subsequently corrected may be considered for enrollment upon investigator assessment)
  • Severe neurological or psychiatric disorders that affect study follow-up or neurological function assessment
  • Clinically significant severe renal impairment, or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
  • Severe hepatic impairment, such as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or total bilirubin (TBIL) ≥ 2 × ULN, or known pre-existing congenital disorder of bilirubin metabolism
  • Within 3 months: acute ST-elevation myocardial infarction (MI), and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or hospitalization due to acute coronary syndrome, MI, or cardiac arrest, or non-elective coronary intervention; or New York Heart Association (NYHA) heart failure Class III/IV; or known ventricular tachycardia
  • History of hemolytic anemia of any cause, currently under treatment or not meeting the criteria for cure
  • Known allergy or intolerance to SIM0811 or its formulation excipients, or to aspirin
  • Women who are pregnant or breastfeeding, or women with a positive pregnancy test
  • Participation in other drug or device clinical studies within 3 months prior to screening
  • End-stage disease with expected survival of less than 1 year
  • Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this trial

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

zhibiao song contact

86-13641133681

songzhibiao@simcere.com

About this study

Official title: A Phase II/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of SIM0811 Injection in Patients With Acute Ischemic Stroke

The study will evaluate the efficacy and safety of SIM0811 in participants with acute ischemic stroke who are present within 4.5 to 24 hours since last known well. The main questions it aims to answer are:

  1. Does SIM0811 improve overall functional outcome, measured by the ability to perform daily activities independently without help 90 days after treatment?
  2. What medical problems do participants have when taking SIM0811? Researchers will compare different doses of SIM0811 to a placebo (a look-alike substance that contains no drug) to see if SIM0811 works to treat acute ischemic stroke.
Read more

Participants will:

  1. Receive SIM0811 or a placebo .
  2. Receive standard medical care for stroke. On the first day, all participants will also take an aspirin pill or an aspirin placebo to keep the treatment assignment a secret.
  3. Stay in the hospital for a few days to undergo medical tests, including CT or MRI scans and blood draws.
  4. Return to the clinic for follow-up visits for up to 90 days to check their recovery and overall health.
Being tested
SIM0811 Dose Level A (Phase II), SIM0811 Dose Level B (Phase II), SIM0811 Dose Level C (Phase II), Placebo(Phase II), SIM0811（Phase III）

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIM0811 Dose Level A (Phase II)Drug

    Participants receive SIM0811 Dose Level A.

  • SIM0811 Dose Level B (Phase II)Drug

    Participants receive SIM0811 Dose Level B.

  • SIM0811 Dose Level C (Phase II)Drug

    Participants receive SIM0811 Dose Level C.

  • Placebo(Phase II)Drug

    Participants receive SIM0811 placebo

  • SIM0811（Phase III）Drug

    Participants receive the selected target dose of SIM0811

  • Placebo(Phase III)Drug

    Participants receive SIM0811 placebo.

Study groups in NCT07903701
Study groupRoleWhat they receive
SIM0811 2 Dose Level A (Phase II)ExperimentalParticipants receive SIM0811 Dose Level A.
Receives: Drug: SIM0811 Dose Level A (Phase II)
SIM0811 Dose Level B (Phase II)ExperimentalParticipants receive SIM0811 Dose Level B.
Receives: Drug: SIM0811 Dose Level B (Phase II)
SIM0811Dose Level C (Phase II)ExperimentalParticipants receive SIM0811 Dose Level C.
Receives: Drug: SIM0811 Dose Level C (Phase II)
Placebo（Phase II）Placebo comparatorParticipants receive SIM0811 placebo.
Receives: Drug: Placebo(Phase II)
SIM0811(Phase III)ExperimentalParticipants receive the selected target dose of SIM0811.
Receives: Drug: SIM0811（Phase III）
Placebo (Phase III)Placebo comparatorParticipants receive SIM0811 placebo.
Receives: Drug: Placebo(Phase III)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at Day 90

    Measured: Day 90

Secondary outcomes (8)

  1. mRS distribution at Day 30 and 90;

    Measured: Day30 Day 90

  2. Proportions of symptomatic intracranial hemorrhage within 36 h, intracranial hemorrhage, and major extracranial hemorrhage 90-day mortality

    Measured: Day 0-Day 90

  3. Number of Participants With Any Adverse Event (AE)

    Measured: Day 0-Day 90

  4. Number of Participants With Treatment-Related Adverse Events (TRAEs)

    Measured: Day 0-Day 90

  5. Number of Participants With Serious Adverse Events (SAEs)

    Measured: Day 0-Day 90

  6. Number of Participants With Clinically Significant Abnormal Laboratory Values

    Measured: Day 0-Day 90

  7. Number of Participants With Clinically Significant Abnormal Vital Signs

    Measured: Day 0-Day 90

  8. Number of Participants With Clinically Significant Abnormal Physical Examination Findings

    Measured: Day 0-Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,092 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07903701
Sponsor's protocol ID
SIM0811-201
Status last verified
Nov 2026
First submitted
23 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SIM0811 Dose Level A (Phase II), SIM0811 Dose Level B (Phase II) and SIM0811 Dose Level C (Phase II) in people with Acute Ischemic Stroke AIS, run by Jiangsu Simcere Pharmaceutical Co., Ltd..

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 7 inclusion and 21 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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 zhibiao song (86-13641133681, songzhibiao@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at Day 90 (time frame: Day 90). 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 NCT07903701.

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 Nov 2026.

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