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.

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

Study Overview

• Status: Recruiting
• Conditions: AIS
• Intervention / Treatment: Drug: BXOS110; Drug: placebo

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 Type: Interventional
• Enrollment (Estimated): 1112
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ming xiao zhang; Phone Number: +86 15910367860; Email: zhangxiaoming@biocells.cn

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Beijing Tiantan Hospital , Capital Medical University
    • Contact: Yongjun Wang; Phone Number: 86-13911172565; Email: yongjunwang111@aliyun.com
    • Principal Investigator: Zixiao Li
  • Hebei
    • Hengshui, Hebei, China
      • Recruiting
      • Harrison International Peace Hospital
      • Contact: Xiaoli Wang; Phone Number: 86-18633680078; Email: hshywxl@163.com
  • Heilongjiang
    • Daqing, Heilongjiang, China
      • Recruiting
      • Daqing Oilfield General Hospital
      • Contact: Dan Deng; Phone Number: 86-18245977799; Email: 707604206@qq.com
  • Henan
    • Nanyang, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Nanyang Medicinal College
      • Contact: Tao Feng; Phone Number: 86-15638996063; Email: 631740898@qq.com
  • Jilin
    • Meihekou, Jilin, China
      • Recruiting
      • Meihekou Central Hospital
      • Contact: Hong Yu; Phone Number: 86-13844564195; Email: 2823974848@qq.com
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The Affiliated Hospital of Shenyang Medical College
      • Contact: Runhui Li; Phone Number: 86-18002477116; Email: lirh710717@163.com
  • Shaanxi
    • Xianyang, Shaanxi, China
      • Recruiting
      • Xianyang Hospital of Yan'an University
      • Contact: Wen Liu; Phone Number: 86-18740505535; Email: 174461442@qq.com
  • Shandong
    • Linyi, Shandong, China
      • Recruiting
      • Linyi People's Hospital
      • Contact: Ziran Wang; Phone Number: 86-13954993801; Email: wzr0806@163.com
  • Shanxi
    • Linfen, Shanxi, China
      • Not yet recruiting
      • Linfen Central Hospital
      • Contact: Hongguo Dai; Phone Number: 86-15935767592; Email: daihongguo3199@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age18~85 (including 18 and 85 years)，no gender limitation;
2. Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
3. 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
4. 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);
5. First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
6. 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).

Exclusion Criteria:

1. Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
2. Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
3. After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
4. Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
5. 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;
6. Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
7. Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years;
8. Patients who have been treated with neuroprotective agents after current stoke onset;
9. Have a epilepsy history or have epilepsy symptoms after current stoke onset;
10. Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
11. Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
12. History of severe head trauma or stroke within 3 months before screening;
13. History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
14. Expected survival period is less than 3 months;
15. Pregnant, planning pregnancy or breastfeeding patients;
16. Suspected or confirmed history of alcohol or drug abuse;
17. Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial;
18. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BXOS110 group; BXOS110 group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg;	Drug: BXOS110; BXOS110，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg
Placebo Comparator: Placebo group; Placebo group :Intravenous infusion administration once,3.0 mg/kg, with a maximum dose of up to 300 mg	Drug: placebo; placebo，Intravenous infusion administration once，3.0 mg/kg, with a maximum dose of up to 300 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with mRS score 0-2 on day 90	day 90(on the day 90 after treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security Indicators	Incidence of serious adverse events (SAE) in each group;; Incidence of hypotension events in each group; Incidence of of hemorrhagic transformation events in each group ；; Incidence of adverse events (AE) in each group;; Incidence of all-cause mortality;; Mortality rate within 90 days due to stroke;; Changes in laboratory test indicators before and after treatment in each group;; Changes in vital signs before and after treatment in each group;; Changes in 12-lead ECG resuts before and after treatment in each group；; Situation of subjects withdrawn from the study for AE reasons.	The entire process of clinical trial,about an average of 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BXOS110-III-2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No