NCT07233070

HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of HRS-7450 Injection in Patients With Acute Ischemic Stroke.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	HRS-7450 Injection	HRS-7450 Injection; low dose
DRUG	HRS-7450 Injection	HRS-7450 Injection; Intermediate dose
DRUG	HRS-7450 Injection	HRS-7450 Injection; high dose
DRUG	HRS-7450 Injection Placebo	HRS-7450 Injection Placebo

Timeline

• Start date: 2025-10-31
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2025-11-18
• Last updated: 2025-11-20

Locations

2 sites across 1 country: China