NCT07404579

Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults

A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bolus-Administered HRS-9190 Versus Rocuronium for Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Rocuronium. The primary objective is to measure the duration from the last dose of the study drug until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	HRS-9190	HRS-9190; high dose(under Inhalational Anesthesia)
DRUG	HRS-9190	HRS-9190; low dose(under Inhalational Anesthesia)
DRUG	HRS-9190	HRS-9190; high dose(under Intravenous Anesthesia)
DRUG	HRS-9190	HRS-9190; low dose(under Intravenous Anesthesia)
DRUG	Rocuronium	Rocuronium(under Inhalational Anesthesia).
DRUG	Rocuronium	Rocuronium(under Intravenous Anesthesia)

Timeline

• Start date: 2026-03-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-02-11
• Last updated: 2026-03-17

Locations

2 sites across 1 country: China