Skeletal Muscle RelaxationPhase 1NCT06932315
A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Subjects
A Phase 1 study testing HRS-9190 for Injection in people with Skeletal Muscle Relaxation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Relaxation
- What is being tested?
- HRS-9190 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2025to 13 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Positive alcohol breath test at screening.
- Pregnancy or lactation status (for female subjects).
- Investigator-determined unsuitability for study participation or predicted protocol non-compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: 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.
- Conditions
- Skeletal Muscle Relaxation
- Being tested
- HRS-9190 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9190 for InjectionDrug
Subject will receive the HRS-9190 injection at different dose levels.
| Study group | Role | What they receive |
|---|---|---|
| HRS-9190 Experimental Group | Experimental | Not described Receives: Drug: HRS-9190 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: From the ICF signing date to Day 7.
Secondary outcomes (3)
The maximum observed concentration of HRS-9190 (Cmax)
Measured: 0 hour to 1.5 hours after administration.
Time to Cmax of HRS-9190 (Tmax)
Measured: 0 hour to 1.5 hours after administration.
Terminal elimination half-life of HRS-9190 (t1/2)
Measured: 0 hour to 1.5 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start23 Apr 2025
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle RelaxationStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932315
- Sponsor's protocol ID
- HRS-9190-101
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06932315
- Acronym / sponsor ID
- HRS-9190-101
- Conditions
- Skeletal Muscle Relaxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-9190 Experimental Group | Experimental | Drug: HRS-9190 for Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9190 for InjectionSubject will receive the HRS-9190 injection at different dose levels. | Drug | HRS-9190 Experimental Group |
Primary outcome
Adverse events (AEs)
Time frame: From the ICF signing date to Day 7.
3 secondary outcomes
The maximum observed concentration of HRS-9190 (Cmax)
Time frame: 0 hour to 1.5 hours after administration.
Time to Cmax of HRS-9190 (Tmax)
Time frame: 0 hour to 1.5 hours after administration.
Terminal elimination half-life of HRS-9190 (t1/2)
Time frame: 0 hour to 1.5 hours after administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-9190 for Injection in people with Skeletal Muscle Relaxation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From the ICF signing date to Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.