NCT06447415

Safety, Tolerability, and Preliminary Efficacy of HRS-7450 Injection in the Treatment of Acute Ischemic Stroke: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled Clinical Trial

Safety, Tolerability, and Preliminary Efficacy of HRS-7450 Injection in the Treatment of Acute Ischemic Stroke: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Single Dose Incremental Phase Ib Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, randomized, double-blind, double-dummy, placebo-controlled, single dose escalation study aimed at evaluating the overall safety, tolerability, and preliminary efficacy of HRS-7450 in patients with acute ischemic stroke.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	HRS-7450	HRS-7450 Injection
DRUG	0.9% sodium chloride injection	0.9% sodium chloride injection

Timeline

• Start date: 2024-08-06
• Primary completion: 2025-03-18
• Completion: 2025-06-11
• First posted: 2024-06-07
• Last updated: 2025-09-29

Locations

1 site across 1 country: China