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.

NCT07520565 | Recruiting Phase 3

• 1 other identifier: BXOS110-III-2025-01
• Study Type: interventional
• Target: 1,112
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

AIS

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with mRS score 0-2 on day 90

  day 90(on the day 90 after treatment)

Secondary Outcomes (1)

• mRS/NIHSS /BI/EQ-5D score

  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..

Other Outcomes (1)

• Security Indicators

  The entire process of clinical trial,about an average of 2 years

Study Arms (2)

BXOS110 group

EXPERIMENTAL

BXOS110 group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg;

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

Drug: placebo

Interventions

BXOS110 DRUG

BXOS110，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg

BXOS110 group

placebo DRUG

placebo，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg

Placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• ≤ 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Biocells (Beijing) Biotech Co.,Ltd: lead

Study Sites (9)

Harrison International Peace Hospital

Hengshui, Hebei, China

RECRUITING

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Nanyang Medicinal College

Nanyang, Henan, China

RECRUITING

MeiHekou Central Hospital

Meihekou, Jilin, China

RECRUITING

The Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

RECRUITING

Xianyang Hospital of Yan'an University

Xianyang, Shaanxi, China

RECRUITING

Linyi People's Hospital

Linyi, Shandong, China

RECRUITING

Linfen Central Hospital

Linfen, Shanxi, China

NOT YET RECRUITING

Beijing Tiantan Hospital , Capital Medical University

Beijing, China

NOT YET RECRUITING

Central Study Contacts

ming xiao zhang

CONTACT

+86 15910367860; zhangxiaoming@biocells.cn

Study Design

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

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: April 9, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-11

Locations

CN (9)