A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Subjects

A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Skeletal Muscle Relaxation
• Intervention / Treatment: Drug: HRS-9190 for Injection

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male and female subjects aged 18 to 45 years (inclusive).
2. Subjects must have no pregnancy plans for the next three months and agree to use highly effective contraception throughout the trial period.
3. Capable of understanding the study requirements and willing to provide written informed consent.

Exclusion Criteria:

1. Presence of any clinically significant condition that could interfere with trial participation.
2. History or current diagnosis of neuromuscular disorders.
3. Major surgery within 6 months pre-screening, or planned surgical procedures during the study.
4. Vaccination received within 1 month prior to screening or planned vaccination during the trial period.
5. Participation in another investigational drug trial within 3 months pre-screening.
6. Clinically significant abnormalities in screening/baseline physical examinations.
7. Positive alcohol breath test at screening.
8. Pregnancy or lactation status (for female subjects).
9. Investigator-determined unsuitability for study participation or predicted protocol non-compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-9190 Experimental Group	Drug: HRS-9190 for Injection; Subject will receive the HRS-9190 injection at different dose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	From the ICF signing date to Day 7.

Secondary Outcome Measures

Outcome Measure	Time Frame
The maximum observed concentration of HRS-9190 (Cmax)	0 hour to 1.5 hours after administration.
Time to Cmax of HRS-9190 (Tmax)	0 hour to 1.5 hours after administration.
Terminal elimination half-life of HRS-9190 (t1/2)	0 hour to 1.5 hours after administration.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: HRS-9190-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No