Neuromuscular BlockadePhase 3NCT07746726
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance in Adults
A Phase 3 study testing HRS-9190 and Rocuronium in people with Neuromuscular Blockade, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- HRS-9190 and Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- 2 Sep 2026to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Yangwen Ou
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 410000
Weifeng Yu
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bolus-Administered HRS-9190 Versus Rocuronium for Tracheal Intubation and Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery
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
- Being tested
- HRS-9190, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9190Drug
HRS-9190
RocuroniumDrug
Rocuronium
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group B | Active comparator | Not described Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation conditions
Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score
Measured: Within 5 minutes after administration of the study drug
Secondary outcomes (9)
Time from last dose to recovery from T1% 25% to TOFr ≥90%
Time from last dose of study drug to recovery from T1% 25% to TOFr ≥90% (minutes)
Measured: Within 2 hours after last dose administration
Time to Tracheal Intubation
Time from administration of study drug to completion of tracheal intubation during the induction period
Measured: Within 5 minutes after administration of study drug during induction
Onset Time
Time from each administration of study drug to maximum suppression of T1%.
Measured: Within 30 minutes after each dose of study drug
Duration of Action
Includes: time from each dose to start of T1% recovery; time to T1% recovery to 10% and 25%; time from last dose to achievement of TOFr 40%, 70%, and 90%
Measured: Up to 2 hours after each dose of study drug
Percentage of Time Maintaining Target Neuromuscular Blockade Level
Proportion of time during which T1% is maintained ≤25% relative to the total drug administration time
Measured: Throughout the drug administration period, up to 6 hours
Time to Tracheal Extubation
Time from the last dose of study drug to removal of the tracheal tube
Measured: up to 2 hours after the last dose of study drug
Recovery Index
Includes: time for T1% recovery from 25% to 75%; time for T1% recovery from 5% to 95%; time from T1% recovery to 10% to achievement of TOFr ≥90%
Measured: up to 2 hours after the last dose of study drug
Anesthesiologist's Overall Satisfaction Score
The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.
Measured: Assessed at the end of the surgical procedure, within 1 hour.
Surgeon's Overall Satisfaction Score
The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.
Measured: Assessed at the end of the surgical procedure, within 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start2 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746726
- Sponsor's protocol ID
- HRS-9190-301
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided