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

NCT07404579 | Completed Phase 2

• 1 other identifier: HRS-9190-202
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Duration of Action after Bolus Dose(s)

  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

  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

  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

  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)

  For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.

Study Arms (6)

Treatment group A: HRS-9190 under Inhalational Anesthesia

EXPERIMENTAL

Drug: HRS-9190

Treatment group B: HRS-9190 under Inhalational Anesthesia

EXPERIMENTAL

Drug: HRS-9190

Treatment group C: HRS-9190 under Intravenous Anesthesia

EXPERIMENTAL

Drug: HRS-9190

Treatment group D: HRS-9190 under Intravenous Anesthesia

EXPERIMENTAL

Drug: HRS-9190

Treatment group E: Rocuronium under Inhalational Anesthesia

ACTIVE COMPARATOR

Drug: Rocuronium

Treatment group F: Rocuronium under Intravenous Anesthesia.

ACTIVE COMPARATOR

Drug: Rocuronium

Interventions

Rocuronium DRUG

Rocuronium(under Inhalational Anesthesia).

Treatment group E: Rocuronium under Inhalational Anesthesia

HRS-9190 DRUG

HRS-9190; high dose(under Inhalational Anesthesia)

Treatment group A: HRS-9190 under Inhalational Anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450004, China

Location

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: March 6, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 26, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-02

Locations

CN (2)