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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1112

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

DRUG

BXOS110

BXOS110，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

Sponsors & Collaborators

  • Biocells (Beijing) Biotech Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520565 on ClinicalTrials.gov