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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06932315

Enrollment

Registered

2025-04-17

Start date

2025-04-23

Completion date

2025-08-13

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletal Muscle Relaxation

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.

Interventions

DRUGHRS-9190 for Injection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026