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Completed

NCT Number: NCT06932315

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

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.

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Key information

Conditions

Skeletal Muscle Relaxation

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

HRS-9190 for Injection

Drug

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

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From the ICF signing date to Day 7.

Secondary outcomes

  1. The maximum observed concentration of HRS-9190 (Cmax)

    Time frame: 0 hour to 1.5 hours after administration.

  2. Time to Cmax of HRS-9190 (Tmax)

    Time frame: 0 hour to 1.5 hours after administration.

  3. Terminal elimination half-life of HRS-9190 (t1/2)

    Time frame: 0 hour to 1.5 hours after administration.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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