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

NCT07746726 | Not Yet Recruiting Phase 3

• 1 other identifier: HRS-9190-301
• Study Type: interventional
• Target: 320
• 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 assess the efficacy of HRS-9190 in providing adequate neuromuscular blockade for successful tracheal intubation. 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)

• 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 Outcomes (9)

• Time from last dose to recovery from T1% 25% to TOFr ≥90%

  Within 2 hours after last dose administration

• Time to Tracheal Intubation

  Within 5 minutes after administration of study drug during induction

• Onset Time

  Within 30 minutes after each dose of study drug

• Duration of Action

  Up to 2 hours after each dose of study drug

• Percentage of Time Maintaining Target Neuromuscular Blockade Level

  Throughout the drug administration period, up to 6 hours

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: HRS-9190

Treatment group B

ACTIVE COMPARATOR

Drug: Rocuronium

Interventions

HRS-9190 DRUG

HRS-9190

Treatment group A

Rocuronium DRUG

Rocuronium

Treatment group B

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:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 410000, China

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Lei Tang

CONTACT

+0518-81220121; lei.tang.lt31@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: July 31, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

CN (2)