Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Ischemic Stroke AIS

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

mRS distribution at Day 30 and 90;
Day30 Day 90
safety and tolerability
Day 0-Day 90

Study Arms (6)

SIM0811 2 Dose Level A (Phase II)

EXPERIMENTAL

Participants receive SIM0811 Dose Level A.

Drug: SIM0811 Dose Level A (Phase II)

SIM0811 Dose Level B (Phase II)

EXPERIMENTAL

Participants receive SIM0811 Dose Level B.

Drug: SIM0811 Dose Level B (Phase II)

SIM0811Dose Level C (Phase II)

EXPERIMENTAL

Participants receive SIM0811 Dose Level C.

Drug: SIM0811 Dose Level C (Phase II)

Interventions

SIM0811 Dose Level A (Phase II)Drug

Participants receive SIM0811 Dose Level A.

SIM0811 2 Dose Level A (Phase II)

SIM0811 Dose Level B (Phase II)Drug

Participants receive SIM0811 Dose Level B.

SIM0811 Dose Level B (Phase II)

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Protocol design
SIM0811 Dose Level A (Phase II)
The registry names a study arm, cohort or protocol phase. This describes the study design and does not establish a chemical identity, product equivalence or actual exposure.
Role as written:
Phase II
Subject as written:
SIM0811 Dose Level A
Registry study type: Interventional
View registry record
Protocol design
SIM0811 Dose Level B (Phase II)
The registry names a study arm, cohort or protocol phase. This describes the study design and does not establish a chemical identity, product equivalence or actual exposure.
Role as written:
Phase II
Subject as written:
SIM0811 Dose Level B
Registry study type: Interventional
View registry record
Protocol design
SIM0811 Dose Level C (Phase II)
The registry names a study arm, cohort or protocol phase. This describes the study design and does not establish a chemical identity, product equivalence or actual exposure.
Role as written:
Phase II
Subject as written:
SIM0811 Dose Level C
Registry study type: Interventional
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years.
Time from last known well: 4.5 to 24 hours.

Sponsors & Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.
Industrylead

MeSH Terms

Interventions

Clinical Trials, Phase II as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

yongjun Wang, professor
Beijing Tiantan Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

zhibiao song

CONTACT

86-13641133681 songzhibiao@simcere.com

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 23, 2026

First Posted

October 29, 2026

Study Start

November 30, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

June 30, 2029

You may not qualify if:

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)
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
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (6)

SIM0811 2 Dose Level A (Phase II)

SIM0811 Dose Level B (Phase II)

SIM0811Dose Level C (Phase II)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Placebo（Phase II）

SIM0811(Phase III)

Placebo (Phase III)

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (6)

SIM0811 2 Dose Level A (Phase II)

SIM0811 Dose Level B (Phase II)

SIM0811Dose Level C (Phase II)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Placebo（Phase II）

SIM0811(Phase III)

Placebo (Phase III)

You may not qualify if:

Data Sharing

Source record