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RECRUITING
NCT07233070
PHASE2

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

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2025-10-31

Completion Date

2027-01

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

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

Locations (2)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Linyi People's Hospital

Linyi, Shandong, China