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

NCT07252921 | Completed Phase 2

• 1 other identifier: HRS-9190-201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

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 (5)

• Time to Maximum Inhibition (Onset Time)

  From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes

• Time to Successful Tracheal Intubation

  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

  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

  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

Study Arms (3)

Treatment group A: HRS-9190

EXPERIMENTAL

Drug: HRS-9190

Treatment group B: HRS-9190

EXPERIMENTAL

Drug: HRS-9190

Treatment group C: Rocuronium Bromide Injection.

ACTIVE COMPARATOR

Drug: HRS-9190

Interventions

HRS-9190 DRUG

HRS-9190; low dose

Treatment group A: HRS-9190

Eligibility Criteria

• Age: 18 Years - 65 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)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

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: November 14, 2025
• First Posted: November 28, 2025
• Study Start: October 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-10

Locations

CN (2)