AISPhase 3NCT07520565
A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.
A Phase 3 study testing BXOS110 in people with AIS, run by Biocells (Beijing) Biotech Co.,Ltd at 9 sites in China.
Trial summary
The purpose of this study was to evaluate the efficacy of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- AIS
- What is being tested?
- BXOS110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,112 participants
- Where
- 9 sitesChina
- Study dates
- 19 Jan 2026to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age18~85 (including 18 and 85 years)，no gender limitation;
- Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
- Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
- First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
- Subjects who are able to understand and comply with the study procedures, and who agree to sign the study informed consent form in writing to indicate that they are willing to participate in the trial (the informed consent form can be signed by subjects or their legal representatives).
Who cannot join
- Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
- Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
- After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
- Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
- Heart rate < 50 beats /min or heart rate > 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months;
- Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
Show all 18Show fewer
- Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years;
- Patients who have been treated with neuroprotective agents after current stoke onset;
- Have a epilepsy history or have epilepsy symptoms after current stoke onset;
- Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
- Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
- History of severe head trauma or stroke within 3 months before screening;
- History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
- Expected survival period is less than 3 months;
- Pregnant, planning pregnancy or breastfeeding patients;
- Suspected or confirmed history of alcohol or drug abuse;
- Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial;
- Other conditions, and the investigator assessed that participation in the study might increase the patient's risk or that participation in the study was deemed inappropriate by the investigator.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Beijing Tiantan Hospital , Capital Medical University
Beijing
Yongjun Wang, 86-13911172565, yongjunwang111@aliyun.com
Zixiao Li
- Recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang
Dan Deng, 86-18245977799, 707604206@qq.com
- Recruiting
Harrison International Peace Hospital
Hengshui, Hebei
Xiaoli Wang, 86-18633680078, hshywxl@163.com
- Not yet recruiting
Linfen Central Hospital
Linfen, Shanxi
Hongguo Dai, 86-15935767592, daihongguo3199@163.com
- Recruiting
Linyi People's Hospital
Linyi, Shandong
Ziran Wang, 86-13954993801, wzr0806@163.com
- Recruiting
MeiHekou Central Hospital
Meihekou, Jilin
Hong Yu, 86-13844564195, 2823974848@qq.com
- Recruiting
The First Affiliated Hospital of Nanyang Medicinal College
Nanyang, Henan
Tao Feng, 86-15638996063, 631740898@qq.com
- Recruiting
The Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning
Runhui Li, 86-18002477116, lirh710717@163.com
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi
Wen Liu, 86-18740505535, 174461442@qq.com
About this study
The purpose of this study was to evaluate the efficacy of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke
Read the detailed description
This trial was conducted in a multicentre, randomised, double-blind, placebo-parallel controlled design, it plans to set up two groups: the BXOS110 treatment group (3.0 mg/kg, with a maximum dose of up to 300 mg), and the placebo group.Each group will consist of 556 participants. The aim is to clarify the efficacy and safety of different doses of BXOS110.
The trial was divided into a screening/baseline period, a treatment period and a follow-up period. In the screening/baseline phase, patients signed an informed consent form within 3 hours of stroke onset to enter the trial, and after completing the screening and procedures related to the trial, subjects who met the enrolment requirements will be randomly assigned to the BXOS110 treatment group, or placebo group in a ratio of 1: 1. During the treatment phase, subjects will be randomly grouped into groups to start the intravenous treatment, and evaluations will be carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects will be evaluated for efficacy and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.
- Conditions
- AIS
- Being tested
- BXOS110, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXOS110Drug
BXOS110，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg
placeboDrug
placebo，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg
| Study group | Role | What they receive |
|---|---|---|
| BXOS110 group | Experimental | BXOS110 group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg; Receives: Drug: BXOS110 |
| Placebo group | Placebo comparator | Placebo group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with mRS score 0-2 on day 90
Measured: day 90(on the day 90 after treatment)
Secondary outcomes (1)
mRS/NIHSS /BI/EQ-5D score
- Proportion of subjects with mRS score 0-1 on day 90;
- Day 90 mRS Displacement Analysis;(The proportion of subjects with different mrs scores)
- Proportion of subjects with NIHSS scores ≤1 or with a ≥4-point reduction in NIHSS score from baseline on day 10 (or at discharge);
- Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation；
- Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90;
- Day 90 European Five Dimensional Health Scale (EQ-5D) Score.(The proportion of subjects with a score of 0)
Measured: The mRS/BI/EQ-5D score assessment will be conducted on the day 90， The NIHSS score assessment will be conducted on the day 10(or at discharge),will be compared with the baseline..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start19 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AISStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocells (Beijing) Biotech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520565
- Sponsor's protocol ID
- BXOS110-III-2025-01
- Status last verified
- Nov 2025
- First submitted
- 12 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.
- ClinicalTrials.gov ID
- NCT07520565
- Acronym / sponsor ID
- BXOS110-III-2025-01
- Conditions
- AIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,112 participants (estimated)
- Lead sponsor
- Biocells (Beijing) Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Apr 2026 (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.
The purpose of this study was to evaluate the efficacy of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke
Detailed description
This trial was conducted in a multicentre, randomised, double-blind, placebo-parallel controlled design, it plans to set up two groups: the BXOS110 treatment group (3.0 mg/kg, with a maximum dose of up to 300 mg), and the placebo group.Each group will consist of 556 participants. The aim is to clarify the efficacy and safety of different doses of BXOS110.
The trial was divided into a screening/baseline period, a treatment period and a follow-up period. In the screening/baseline phase, patients signed an informed consent form within 3 hours of stroke onset to enter the trial, and after completing the screening and procedures related to the trial, subjects who met the enrolment requirements will be randomly assigned to the BXOS110 treatment group, or placebo group in a ratio of 1: 1. During the treatment phase, subjects will be randomly grouped into groups to start the intravenous treatment, and evaluations will be carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects will be evaluated for efficacy and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BXOS110 group | Experimental | Drug: BXOS110BXOS110 group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg; |
| Placebo group | Placebo comparator | Drug: placeboPlacebo group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age18~85 (including 18 and 85 years)，no gender limitation;
- Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
- Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
- First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
Key exclusion criteria (18 listed)
- Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
- Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
- After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
- Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
- Heart rate < 50 beats /min or heart rate > 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months;
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 |
|---|---|---|
| BXOS110BXOS110，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg | Drug | BXOS110 group |
| placeboplacebo，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg | Drug | Placebo group |
Primary outcome
Proportion of subjects with mRS score 0-2 on day 90
Time frame: day 90(on the day 90 after treatment)
1 secondary outcome
mRS/NIHSS /BI/EQ-5D score
Time frame: The mRS/BI/EQ-5D score assessment will be conducted on the day 90， The NIHSS score assessment will be conducted on the day 10(or at discharge),will be compared with the baseline..
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 9 Apr 2026.
Related trials for AIS
Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
Active, not recruiting
Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol
Adolescent Idiopathic Scoliosis (AIS)
RecruitingPhase 1
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
Metastatic Castration-resistant Prostate Cancer (mCRPC)
RecruitingObservational study
Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire
Scoliosis; Adolescence, Adolescent
RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BXOS110 in people with AIS, run by Biocells (Beijing) Biotech Co.,Ltd at 9 sites 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 18 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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 ming xiao zhang (+86 15910367860, zhangxiaoming@biocells.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with mRS score 0-2 on day 90 (time frame: day 90(on the day 90 after treatment)). 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 9 Apr 2026.