Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

Recruiting now · Phase 2

Conditions studied: Neuromuscular Blockade

In brief

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 Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. 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.

Key facts

Study ID

NCT07446309

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

60

Starts

2026-04-10

Expected to finish

2026-07-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• ZhongShan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Shanxi Provincial People'S Hospital — Taiyuan, Shanxi, China (enrolling)

Full record on ClinicalTrials.gov

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