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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A: HRS-9190

Group Type EXPERIMENTAL

HRS-9190

Intervention Type DRUG

HRS-9190; low dose

Treatment group B: HRS-9190

Group Type EXPERIMENTAL

HRS-9190

Intervention Type DRUG

HRS-9190; high dose

Treatment group C: Rocuronium Bromide Injection.

Group Type ACTIVE_COMPARATOR

HRS-9190

Intervention Type DRUG

Rocuronium Bromide Injection

Interventions

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HRS-9190

HRS-9190; low dose

Intervention Type DRUG

HRS-9190

HRS-9190; high dose

Intervention Type DRUG

HRS-9190

Rocuronium Bromide Injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No