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

NCT ID: NCT06932315

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2025-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skeletal Muscle Relaxation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HRS-9190 Experimental Group

Group Type EXPERIMENTAL

HRS-9190 for Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HRS-9190 for Injection

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRS-9190-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.