NCT05690711

A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.

Conditions

• Brain Swelling, Large Hemispheric Infarction

Interventions

Type	Name	Description
DRUG	HRS8179	HRS8179 injection
DRUG	Placebo	physiological saline

Timeline

• Start date: 2023-04-07
• Primary completion: 2023-12-05
• Completion: 2024-02-27
• First posted: 2023-01-19
• Last updated: 2025-01-06

Locations

1 site across 1 country: China