NCT07446309 Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults
| NCT ID | NCT07446309 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Neuromuscular Blockade |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-04-10 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia surgery 3. Meet specified age and body mass index (BMI) criteria 4. Conform to the ASA Physical Status Classification 5. Use of highly effective contraception for a specified period if applicable Exclusion Criteria: 1. Scheduled for specific high-risk surgical procedures 2. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders 3. History of conditions affecting drug metabolism or anesthesia risk 4. Abnormal laboratory values indicating significant clinical abnormalities 5. Positive serology for specified infectious diseases 6. Known hypersensitivity to related medications 7. Recent use of medications interfering with neuromuscular function 8. History of mental illness, cognitive impairment, or epilepsy 9. Participation in another clinical trial within a specified period 10. Any other condition deemed unsuitable by the investigator 11. Pregnant or nursing women 12. Unwilling to use birth control during the specified period
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07446309 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Neuromuscular Blockade. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07446309 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07446309 currently recruiting?
Yes, NCT07446309 is actively recruiting participants. Contact the research team at lei.tang.lt31@hengrui.com for enrollment information.
Where is the NCT07446309 trial being conducted?
This trial is being conducted at Shanghai, China, Taiyuan, China.
Who is sponsoring the NCT07446309 clinical trial?
NCT07446309 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 60 participants.