Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Skeletal Muscle Relaxation
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label and dose-escalation study to evaluate the safety, tolerability and dose-response relationship of HRS-9190 in healthy adults.
Eligibility Criteria
Inclusion
- Healthy male and female subjects aged 18 to 45 years (inclusive).
- Subjects must have no pregnancy plans for the next three months and agree to use highly effective contraception throughout the trial period.
- Capable of understanding the study requirements and willing to provide written informed consent.
Exclusion
- Presence of any clinically significant condition that could interfere with trial participation.
- History or current diagnosis of neuromuscular disorders.
- Major surgery within 6 months pre-screening, or planned surgical procedures during the study.
- Vaccination received within 1 month prior to screening or planned vaccination during the trial period.
- Participation in another investigational drug trial within 3 months pre-screening.
- Clinically significant abnormalities in screening/baseline physical examinations.
- Positive alcohol breath test at screening.
- Pregnancy or lactation status (for female subjects).
- Investigator-determined unsuitability for study participation or predicted protocol non-compliance.
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06932315
Start Date
April 23 2025
End Date
August 8 2025
Last Update
August 26 2025
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013