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

StatusCompleted
PhasePhase 2
Started2026-04-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
notable
Study Status, Study Design, Contacts/Locations v2
Trial completed
Final enrollment: 67 participants (planned 60)
Primary completion dateestimated 2026-07→confirmed 2026-07-14
Completion dateestimated 2026-07→confirmed 2026-07-29
Enrollment targetestimated 60→confirmed 67
Study sitesdetails revised at 2 of 2 sites
2026-04-22
notable
Study Status, Contacts/Locations v1
Recruitment opened
Start date2026-02→2026-04-10
Study sitesdetails revised at 2 of 2 sites
2026-02-26
minor
Original filing
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.
Trial Details
NCT Number NCT07446309
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Neuromuscular Blockade
Enrollment 67 participants
Start Date 2026-04-10
Primary Completion 2026-07-14 (estimated)
Study Completion 2026-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-08