NCT07520565

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,112 (estimated)
• Sponsor: Biocells (Beijing) Biotech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-19
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

9 sites across 1 country: China