NCT06322394

BXOS110 Injection in the Treatment of Acute Ischaemic Stroke

A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (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 effectiveness 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, with a total of three groups of 100 subjects in each of the three planned groups, namely, the BXOS110 high-dose group (3.0 mg/kg, with a maximum dose of up to 300 mg), the BXOS110 low-dose group (2.0 mg/kg, with a maximum dose of up to 200 mg) and the placebo-control group, with the aim of exploring the efficacy and safety of BXOS110 at different doses of BXOS110. efficacy and safety 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 were randomly assigned to the BXOS110 high-dose group, the BXOS110 low-dose group, or a placebo-controlled group in a ratio of 1: 1: 1. During the treatment phase, subjects were randomly grouped into groups to start the intravenous treatment, and evaluations were carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects were evaluated for effectiveness and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	high-dose BXOS110	3.0 mg/kg, maximum dose not exceeding 300 mg，Participants received one administration by intravenous infusion.
DRUG	low-dose BXOS110	2.0 mg/kg, maximum dose not exceeding 200 mg，Participants received one administration by intravenous infusion.
DRUG	Placebo	Does not contain any test drug active ingredients，Participants received one administration by intravenous infusion.

Timeline

• Start date: 2024-02-07
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

24 sites across 1 country: China