Efficacy and Safety of HRS-9190 in General Anesthesia

NCT07733245 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: HRS-9190-301
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double - blind, placebo - controlled, parallel - group phase III clinical trial was carried out to evaluate the efficacy and safety of HRS - 9190 for skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The primary objective was to evaluate the effectiveness of HRS - 9190 in achieving skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The secondary objective was to assess the safety and pharmacokinetic profile of HRS - 9190.

Conditions

Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery

Keywords

Anesthesia; Muscle relaxants

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with excellent or good intubation conditions at the time of tracheal intubation

  Cooper score evaluation of tracheal intubation conditions: excellent, 8 - 9 points; good, 6 - 7 points; fair, 3 - 5 points; poor, 0 - 2 points.

  From the beginning of the drug to 5 minutes after the administration

Secondary Outcomes (8)

• Time (minutes) required for the recovery of the myotwitch height value (T1) from 25% until the Train-of-Four ratio (TOFr) reaches ≥90%

  During the last administration to 2 hours after administration, the TOFr of muscle relaxation monitoring was ≥90%

• Time to complete tracheal intubation

  Time to complete tracheal intubation within 5 minutes after the start of drug administration

• Time to onset

  The time to achieve T1% maximal inhibition was monitored with a muscle relaxometer from the beginning of the dose until 5 min after the dose

• Action time

  Perioperative

• Percentage of time T1%≤25%

  Perioperative

Other Outcomes (1)

• Adverse events

  Randomization to the day after surgery

Study Arms (2)

HRS-9190 group

EXPERIMENTAL

Drug: Administration of intravenous HRS-9190

Control group

ACTIVE COMPARATOR

Drug: Administration of intravenous rocuronium

Interventions

Administration of intravenous HRS-9190 DRUG

During the induction phase, 0.6 mg/kg of HRS-9190 was administered intravenously, and during the maintenance phase, 0.2 mg/kg of HRS-9190 was administered intravenously.

HRS-9190 group

Administration of intravenous rocuronium DRUG

During the induction phase, 0.6 mg/kg of rocuronium was administered intravenously, and during the maintenance phase, 0.15 mg/kg of rocuronium was administered intravenously.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign ICF before starting trial-related activities, fully understand the purpose and significance of this trial, and voluntarily abide by the process of this trial;
• For elective surgery, tracheal intubation should be performed under general anesthesia and intermittent drug administration is suitable for intraoperative muscle relaxation maintenance, and the operation time is expected to be 1.5-4 hours; 3.18 years old ≤ age ≤75 years old, regardless of gender;
• \. 18.0 kg/m2≤ body mass index (BMI) ≤28.0 kg/m2; 5. ASA grade I-II; 6. Female participants of childbearing potential must agree to use highly effective contraception with their partner and avoid egg donation from the time they sign the ICF until 1 month after the last dose of the investigational drug, have a negative serum pregnancy test during the screening period, and are not lactating; Men whose partner was a woman of childbearing potential agreed to use highly effective contraception with their partner and to avoid sperm donation from the time they signed the ICF until 1 month after the last dose of the investigational product.

You may not qualify if:

• previous neuromuscular diseases: myasthenia gravis, myasthenic syndromes, myotonic disorders, poliomyelitis, etc. Previous immune diseases requiring long-term steroid therapy (3 months or more);
• a history of myocardial infarction or unstable angina, a history of severe arrhythmia such as atrioventricular block degree II or higher, or a history of New York Heart Association (NYHA) functional class II or higher within 6 months before screening that was deemed by the investigator to increase the risk of sedation/anesthesia; Participants with hypertension or hypotension who had poorly controlled blood pressure (systolic blood pressure ≥160 mmHg or ≤90 mmHg at screening; and/or diastolic blood pressure ≥100 mmHg or ≤60 mmHg at screening); Previous history of ischemic stroke or transient ischemic attack (TIA); Participants with psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive impairment, or a history of epilepsy, or previous history of psychotropic or narcotic drug abuse;
• The presence of severe respiratory diseases such as chronic obstructive pulmonary disease or bronchial asthma; Or those with obstructive sleep apnea syndrome, as assessed by investigators, who might be at risk for difficult intubation;
• abnormal body temperature \>37.5℃ or \<36℃ during the screening period; He had a history of malignant high fever. Hypothermia surgery was planned.
• having a history of drug, drug, or alcohol abuse within 1 year before randomization
• QTc (QTcF= QT/RR0.33) : male \>450 ms, female \>470 ms;
• Abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥1.5 times upper limit of normal (ULN) and/or total bilirubin (TBIL) ≥1.5 times ULN; Abnormal renal function during screening: serum creatinine (Cr) ≥1.5 times upper limit of normal (ULN); Serum albumin (ALB) during screening was less than 35g/L;
• electrolyte disturbance or known dehydration, acid/alkalosis, hypercapnia, or other factors assessed by the investigator during the screening period;
• positive for human immunodeficiency virus (HIV) antibody, syphilis antibody, hepatitis B surface antigen, and hepatitis C virus (HCV) antibody;
• previous allergy to neuromuscular blocking drugs or other drugs that may be used during the trial;
• use other drugs that affect the effect of muscle relaxant, and the interval between the last use and the random time is less than 5 half-lives (according to the actual drug instructions, the half-life is unknown, then the elution is according to 48 hours) : Neuromuscular blockers, cholinesterase inhibitors or cholinergic drugs, monoamine oxidase inhibitors, antibiotics, diuretics, antiarrhythmic drugs and local anesthetics, anticonvulsants and psychotropic drugs; Other
• participated in another drug (defined as receipt of a trial drug or placebo) or device clinical trial within 3 months before screening;
• other circumstances that the investigator judged the participant to be ineligible for participation in the trial.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University, Changsha, hunan

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent dispensing personnel were designated to conduct the trial, and both evaluators and participants remained blinded throughout. The trial drug was administered in accordance with the protocol. After blind verification, data were locked; the statistician then submitted an unblinding request. Specifically, the randomization and drug assignment codes were disclosed only to authorized statistical personnel to enable full analysis. Double-blinding was maintained unless broken for urgent clinical reasons-e.g. , serious adverse events or life-threatening emergencies-upon investigator decision, following immediate notification to the monitor, principal investigator, and sponsor. Unblinding authorization was pre-registered in the RTSM system. Once unblinded, the participant was classified as discontinued.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 29, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)