NCT06517173

Y-3 for Injection in the Treatment of Acute Ischemic Stroke

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Y-3 in Chinese Subjects with Acute Ischemic Stroke

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 998 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to evaluate the effectiveness and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset

Detailed description

A multi-center, randomized, double-blind, parallel, placebo-controlled trial design was adopted, and subjects were randomly assigned to Y-3 for injection group and placebo group in a 1:1 ratio. randomization stratification factors include: onset time (≤12 hours, \>12 hours) and research site. Treatment was continued for 10 days (10 times), and follow-up was conducted until the 90th day from the first dose. The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase. Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination. Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 10 days (10 times) with Y-3 for injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out; PK blood samples from subjects were collected for population pharmacokinetic analysis. Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Y-3 for injection	Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
DRUG	Placebo control group	Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.

Timeline

• Start date: 2024-07-24
• Primary completion: 2024-12-01
• Completion: 2025-07-01
• First posted: 2024-07-24
• Last updated: 2024-09-19

Locations

1 site across 1 country: China