NCT07252921

Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults

A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of HRS-9190 for Injection as a Neuromuscular Blocking Agent for Tracheal Intubation During General Anesthesia Induction in Adult Patients Undergoing Elective Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia with tracheal intubation. Participants will be randomly assigned to receive either HRS-9190 for Injection or Rocuronium. The primary objective is to assess the efficacy of HRS-9190 in providing adequate neuromuscular blockade for successful tracheal intubation. Secondary objectives include evaluating the onset time, duration of action, and recovery profile of neuromuscular blockade. 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 for tracheal intubation, with a satisfied safety profile in the target patient population.

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	HRS-9190	HRS-9190; low dose
DRUG	HRS-9190	HRS-9190; high dose
DRUG	HRS-9190	Rocuronium Bromide Injection

Timeline

• Start date: 2025-10-30
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-11-28
• Last updated: 2026-01-29

Locations

2 sites across 1 country: China