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.

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450004
      • Henan Provincial People's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Shanghai Jiaotong University School of Medicine, Renji Hospital

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-9190 under Inhalational Anesthesia	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)
Experimental: Treatment group B: HRS-9190 under Inhalational Anesthesia	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)
Experimental: Treatment group C: HRS-9190 under Intravenous Anesthesia	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)
Experimental: Treatment group D: HRS-9190 under Intravenous Anesthesia	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)
Active Comparator: Treatment group E: Rocuronium under Inhalational Anesthesia	Drug: Rocuronium; Rocuronium(under Inhalational Anesthesia).; Drug: Rocuronium; Rocuronium(under Intravenous Anesthesia)
Active Comparator: Treatment group F: Rocuronium under Intravenous Anesthesia.	Drug: Rocuronium; Rocuronium(under Inhalational Anesthesia).; Drug: Rocuronium; Rocuronium(under Intravenous Anesthesia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from Last Dose to Recovery of TOFr to 0.9	The duration (in minutes) from the administration of the last dose of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater	From the administration of the last dose of the study drug until TOFr ≥ 0.9 is achieved, assessed intraoperatively and in the recovery period, up to 2 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Action after Bolus Dose(s)	The time (in minutes) from each bolus administration (including the initial dose for induction) to: 1) the start of T1 recovery; 2) recovery of T1 to 10% of baseline; 3) recovery of T1 to 25% of baseline.	For each bolus dose: from administratin until specified recovery points, assessed intraoperatively, up to 2 hours.
Time from Last Dose to Specific TOFr Recovery Milestones	The time (in minutes) from the last dose to the recovery of TOFr to 0.4 and to 0.7.	From the administration of the last dose of the study drug until specified TOFr values are achieved, assessed intraoperatively and in recovery, up to 2 hours.
Percentage of Time with Target Neuromuscular Block	The proportion (%) of the total drug administration period during which adequate surgical relaxation (T1 ≤ 25% of baseline) is maintained.	From the first administration of the study drug until the end of the last maintenance dose requirement, assessed intraoperatively, up to 6 hours.
Time to Successful Airway Device Placement	The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement.	From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 2-5 minutes.
Onset Time after Bolus Dose(s)	The time (in minutes) from each bolus administration (including for induction) to the time of maximum T1 depression (peak effect).	For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.
Time from Last Dose to Airway Device Removal	The time (in minutes) from the last dose of the study drug to the removal of the tracheal tube or laryngeal mask.	From the administration of the last dose of the study drug to tracheal extubation or laryngeal mask removal, assessed at the end of surgery until device removal, up to 2 hours.
Recovery Index	The recovery time (in minutes) for T1 to recover from 25% to 75% of baseline, and from 5% to 95% of baseline, following the last dose.	After the last dose: from T1=25% to T1=75%, and from T1=5% to T1=95%, assessed intraoperatively and in recovery, up to 2 hours.
Anesthesiologist's Overall Satisfaction Score	The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.	Assessed at the end of the surgical procedure, within 1 hour.
Surgeon's Overall Satisfaction Score	The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.	Assessed at the end of the surgical procedure, within 1 hour.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Actual): May 15, 2026
• Study Completion (Actual): May 26, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstanes; Androstanols; Rocuronium
• Other Study ID Numbers: HRS-9190-202

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