Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Neuromuscular Blockade

Treatments: Drug: HRS-9190

Study type: Interventional

Funder types: Industry

Identifiers

NCT07252921

HRS-9190-201

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 3 patient groups

Treatment group A: HRS-9190

Experimental group

Treatment:

Drug: HRS-9190

Drug: HRS-9190

Drug: HRS-9190

Treatment group B: HRS-9190

Experimental group

Treatment:

Drug: HRS-9190

Drug: HRS-9190

Drug: HRS-9190

Treatment group C: Rocuronium Bromide Injection.

Active Comparator group

Treatment:

Drug: HRS-9190

Drug: HRS-9190

Drug: HRS-9190