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

NCT06932315 | Completed Phase 1

• 1 other identifier: HRS-9190-101
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Skeletal Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  From the ICF signing date to Day 7.

Secondary Outcomes (3)

• 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.

Study Arms (1)

HRS-9190 Experimental Group

EXPERIMENTAL

Drug: HRS-9190 for Injection

Interventions

HRS-9190 for Injection DRUG

Subject will receive the HRS-9190 injection at different dose levels.

HRS-9190 Experimental Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: April 23, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CN (1)