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

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: HRS-9190; Drug: HRS-9190; Drug: HRS-9190

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • The Third Xiangya Hospital of Central South University
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia surgery
3. Meet specified age and body mass index (BMI) criteria
4. Conform to the ASA Physical Status Classification
5. Use of highly effective contraception for a specified period if applicable

Exclusion Criteria:

1. Scheduled for specific high-risk surgical procedures
2. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders
3. History of conditions affecting drug metabolism or anesthesia risk
4. Abnormal laboratory values indicating significant clinical abnormalities
5. Positive serology for specified infectious diseases
6. Known hypersensitivity to related medications
7. Recent use of medications interfering with neuromuscular function
8. History of mental illness, cognitive impairment, or epilepsy
9. Participation in another clinical trial within a specified period
10. Any other condition deemed unsuitable by the investigator
11. Pregnant or nursing women
12. Unwilling to use birth control during the specified period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-9190	Drug: HRS-9190; HRS-9190; low dose; Drug: HRS-9190; HRS-9190; high dose; Drug: HRS-9190; Rocuronium Bromide Injection
Experimental: Treatment group B: HRS-9190	Drug: HRS-9190; HRS-9190; low dose; Drug: HRS-9190; HRS-9190; high dose; Drug: HRS-9190; Rocuronium Bromide Injection
Active Comparator: Treatment group C: Rocuronium Bromide Injection.	Drug: HRS-9190; HRS-9190; low dose; Drug: HRS-9190; HRS-9190; high dose; Drug: HRS-9190; Rocuronium Bromide Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation conditions	Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score	Within 5 minutes after administration of the study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Maximum Inhibition (Onset Time)	The time from the start of injection of the study drug to the time when T1 reaches 0% of its baseline value, indicating complete neuromuscular blockade and maximum drug effect.	From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes
Time to Successful Tracheal Intubation	The time from the start of injection of the study drug to the time when the endotracheal tube is correctly placed and secured, as confirmed by the anesthesiologist.	From start of study drug administration to the completion of tracheal intubation, Estimated within 5 minutes
Time to Recovery of T1 to 10%/25% of Baseline	The duration of action measured as the time from injection to the time when the first twitch (T1) recovers to 10%/25% of its pre-drug baseline height.	From start of study drug administration until the time when T1 recovers to 10% /25% of its baseline value, Estimated within 30 minutes
Time to Recovery of Train-of-Four Ratio (TOFr) to 0.4/0.7/0.9	The time from injection to recovery of the ratio of the fourth twitch (T4) to the first twitch (T1) to 0.4, which is a marker of adequate recovery for spontaneous ventilation.	From start of study drug administration until the time when the TOFr recovers to 0.4/0.7/0.9, Estimated from 15 to 90 minutes
Recovery Index (T1 25% to 75% and T1 5% to 95%)		within 2 hours after administration of research drug

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HRS-9190-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No