Neuromuscular BlockadePhase 2NCT07252921
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults
A Phase 2 study testing HRS-9190 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 with tracheal intubation. 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 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- HRS-9190
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- 30 Oct 2025to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 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
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of HRS-9190 for Injection as a Neuromuscular Blocking Agent for Tracheal Intubation During General Anesthesia Induction in Adult Patients Undergoing Elective Surgery
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
- Being tested
- HRS-9190
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9190Drug
HRS-9190; low dose
HRS-9190Drug
HRS-9190; high dose
HRS-9190Drug
Rocuronium Bromide Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-9190 | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group B: HRS-9190 | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group C: Rocuronium Bromide Injection. | Active comparator | Not described Receives: Drug: HRS-9190 |
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 (5)
Time to Maximum Inhibition (Onset Time)
The time from the start of injection of the study drug to the time when T1 reaches 0% of its baseline value, indicating complete neuromuscular blockade and maximum drug effect.
Measured: From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes
Time to Successful Tracheal Intubation
The time from the start of injection of the study drug to the time when the endotracheal tube is correctly placed and secured, as confirmed by the anesthesiologist.
Measured: 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
The duration of action measured as the time from injection to the time when the first twitch (T1) recovers to 10%/25% of its pre-drug baseline height.
Measured: 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
The time from injection to recovery of the ratio of the fourth twitch (T4) to the first twitch (T1) to 0.4, which is a marker of adequate recovery for spontaneous ventilation.
Measured: 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%)
Measured: within 2 hours after administration of research drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Oct 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
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
- NCT07252921
- Sponsor's protocol ID
- HRS-9190-201
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of HRS-9190 for Injection as a Neuromuscular Blocking Agent for Tracheal Intubation During General Anesthesia Induction in Adult Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT07252921
- Acronym / sponsor ID
- HRS-9190-201
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9190HRS-9190; low dose | Drug | Treatment group A: HRS-9190 |
| HRS-9190HRS-9190; high dose | Drug | Treatment group B: HRS-9190 |
| HRS-9190Rocuronium Bromide Injection | Drug | Treatment group C: Rocuronium Bromide Injection. |
Primary outcome
Intubation conditions
Time frame: Within 5 minutes after administration of the study drug
Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score
5 secondary outcomes
Time to Maximum Inhibition (Onset Time)
Time frame: From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes
Time to Successful Tracheal Intubation
Time frame: 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
Time frame: 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
Time frame: 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%)
Time frame: within 2 hours after administration of research drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-9190 in people with Neuromuscular Blockade, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation conditions (time frame: Within 5 minutes after administration of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.