Skeletal Muscle RelaxationPhase 1NCT07142850
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HRS-9190 in Healthy Adults
A Phase 1 study testing HRS-9190 in people with Skeletal Muscle Relaxation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is divided into two parts. The first part adopts a single-center, randomized, single-blind, placebo-controlled dose escalation trial design to investigate the safety, tolerability, pharmacokinetics (PK), and effects on the QTc interval in healthy subjects after a single administration of HRS-9190 for… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2025to 31 Oct 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
- Before the trial, the subjects have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial. They can understand the procedures and methods of this study, are willing to strictly abide by the requirements of the entire clinical study, and voluntarily sign the informed consent form.
- Aged between 18 and 45 years (inclusive) at the time of signing the informed consent form, with both males and females eligible;
- ASA physical status classification of Class I;
- At the screening period, male subjects must weigh ≥50 kg, female subjects must weigh ≥45 kg, and the body mass index (BMI = weight (kg)/height² (m²)) is between 19 and 28 kg/m² (inclusive);
- Female subjects of childbearing potential must agree to use highly effective contraception and avoid donating eggs from the time of signing the informed consent form until 3 months after the last dose of the investigational product. Serum pregnancy tests at the screening and baseline periods must be negative, and they must not be breastfeeding. Male subjects whose partners are females of childbearing potential must agree to use highly effective contraception and avoid donating sperm from the time of signing the informed consent form until 3 months after the last dose of the investigational product.
Who cannot join
- Subjects with a history or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic abnormalities, who are deemed unsuitable for enrollment by the investigator;
- Subjects with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism) or a history of poliomyelitis;
- Subjects with a history of anesthetic complications (such as a history of malignant hyperthermia or a family history of malignant hyperthermia, or those susceptible to malignant hyperthermia (patients with congenital diseases such as idiopathic scoliosis, strabismus, ptosis, umbilical hernia, inguinal hernia, etc.));
- Subjects with a history of asthma, a history of airway diseases requiring treatment or anatomical airway abnormalities, or signs of airway abnormalities assessed during screening airway examination that may affect laryngoscope insertion or tracheal intubation;
- During the screening or baseline period: subjects with clinically significant abnormal physical examination results as judged by the study doctor; subjects with clinically significant abnormal electrocardiograms or those with persistently/repeatedly QTcF > 450 ms in males and > 470 ms in females; subjects with hyperkalemia or hypokalemia that are judged by the investigator to be abnormal and clinically significant;
- Subjects with a known history of allergy to the study drug or its excipients, or those with an allergic constitution (allergic to 2 or more drugs and foods);
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- Subjects who have undergone major surgery within 6 months before screening, or have a history of surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the study drug (such as liver or kidney transplantation), or plan to undergo surgery during the trial;
- Subjects with contraindications to the following drugs (midazolam, propofol, sufentanil, neostigmine, atropine, and sevoflurane): acute angle-closure glaucoma, allergy to eggs, egg products, soybeans or soybean products, epilepsy, angina pectoris, ventricular tachycardia, mechanical intestinal obstruction, urinary tract obstruction, arrhythmia, sinus bradycardia, hypotension, increased vagal tone, benign prostatic hyperplasia, high fever, moderate/moderate hepatic insufficiency, and the following symptoms related to halogenated anesthetics (liver dysfunction, jaundice, fever, or eosinophilia), etc.;
- Subjects who have used any drugs that inhibit or induce hepatic drug metabolism (such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 1 month before drug administration;
- Subjects who have taken antihistamines or antidepressants within 3 months before screening;
- Subjects who have been vaccinated within 1 month before screening or plan to be vaccinated during the trial;
- Subjects who have used any drugs or health products (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before drug administration, or who are known to may need to receive other drug treatments during the trial period as determined during screening;
- Subjects who have participated in a clinical trial and received the trial drug within 3 months before screening, or plan to participate in other clinical trials during the trial period;
- Subjects who have donated blood/lost ≥ 400 mL of blood (except for physiological blood loss in women), received blood transfusion or used blood products within 3 months before screening, or plan to donate blood during the trial or within 1 month after the end of the trial;
- Subjects who smoked more than 5 cigarettes per day on average within 3 months before screening, or cannot quit smoking during the trial;
- Subjects who drank more than 14 units of alcohol per week on average within 3 months before screening (1 unit ≈ 285 mL of beer with 3.5% alcohol content, or 25 mL of spirits with 40% alcohol content, or 85 mL of wine with 12% alcohol content), or who do not agree to abstain from alcohol during the trial;
- Subjects who drank excessive tea, coffee, or caffeinated beverages (on average more than 8 cups per day, 1 cup = 200 mL) within 3 months before screening;
- Subjects who consumed special foods (such as grapefruit, grapefruit juice or foods/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeine-containing foods or beverages, etc.) within 48 hours before drug administration;
- Subjects with positive results in one or more of the tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis, or human immunodeficiency virus antibody;
- Subjects with a history of drug abuse or positive drug abuse screening results;
- Subjects with positive alcohol breath screening results;
- Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
- Female subjects who are pregnant or breastfeeding;
- Subjects who may not be able to complete the study for other reasons or who are deemed unsuitable for inclusion by the investigator.
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
This study is divided into two parts. The first part adopts a single-center, randomized, single-blind, placebo-controlled dose escalation trial design to investigate the safety, tolerability, pharmacokinetics (PK), and effects on the QTc interval in healthy subjects after a single administration of HRS-9190 for injection at doses of 3 times or 6 times the ED95.
The second part uses a single-center, open-label trial design to examine the safety, tolerability, PK, pharmacodynamics (PD), and reversal effect of neostigmine (in combination with atropine) after intravenous bolus injection and continuous intravenous infusion of the loading dose (2 times the ED95) of HRS-9190 under different anesthesia regimens.
- Conditions
- Skeletal Muscle Relaxation
- Being tested
- HRS-9190
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9190Drug
HRS-9190
| Study group | Role | What they receive |
|---|---|---|
| Group A: Intravenous injection, 3×ED95 | Experimental | Not described Receives: Drug: HRS-9190 |
| Group B: Intravenous injection, 6×ED95 | Experimental | Not described Receives: Drug: HRS-9190 |
| Group C: 2×ED95 (intravenous bolus) + intravenous infusion | Experimental | Not described Receives: Drug: HRS-9190 |
| Group D: 2×ED95 (intravenous bolus) + intravenous infusion | Experimental | Not described Receives: Drug: HRS-9190 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: from ICF signing date to Day 7
Plasma histamine levels
Measured: 10 minutes before midazolam administration and 40 minutes after administration
Secondary outcomes (17)
AUC0-t of HRS-9190
Measured: 0 hour to 8 hour after administration
AUC0 inf of HRS-9190
Measured: 0 hour to 8 hour after administration
Cmax of HRS-9190
Measured: 0 hour to 8 hour after administration
Tmax of HRS-9190
Measured: 0 hour to 8 hour after administration
t1/2 of HRS-9190
Measured: 0 hour to 8 hour after administration
CL of HRS-9190
Measured: 0 hour to 8 hour after administration
λz of HRS-9190
Measured: 0 hour to 8 hour after administration
VZ of HRS-9190
Measured: 0 hour to 8 hour after administration
VSS of HRS-9190
Measured: 0 hour to 8 hour after administration
MRTinf of HRS-9190
Measured: 0 hour to 8 hour after administration
AUC%Extrap of HRS-9190
Measured: 0 hour to 8 hour after administration
The C-QTc relationship of HRS-9190.
Measured: At least 90 minutes before the administration of midazolam to 24 hours after the administration of the investigational product
The maximum percentage of T1 suppression
Measured: 0 hour to about 1 hour after the end of infusion
Onset time
Measured: 0 hour to about 1 hour after the end of infusion
Duration of action
Measured: 0 hour to about 1 hour after the end of infusion
Recovery time
Measured: 0 hour to about 1 hour after the end of infusion
Recovery index
Measured: 0 hour to about 1 hour after the end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start26 Aug 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 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
- NCT07142850
- Sponsor's protocol ID
- HRS-9190-102
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 28 Nov 2025
- 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HRS-9190 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07142850
- Acronym / sponsor ID
- HRS-9190-102
- Conditions
- Skeletal Muscle Relaxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 27 Aug 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 study is divided into two parts. The first part adopts a single-center, randomized, single-blind, placebo-controlled dose escalation trial design to investigate the safety, tolerability, pharmacokinetics (PK), and effects on the QTc interval in healthy subjects after a single administration of HRS-9190 for injection at doses of 3 times or 6 times the ED95.
The second part uses a single-center, open-label trial design to examine the safety, tolerability, PK, pharmacodynamics (PD), and reversal effect of neostigmine (in combination with atropine) after intravenous bolus injection and continuous intravenous infusion of the loading dose (2 times the ED95) of HRS-9190 under different anesthesia regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Intravenous injection, 3×ED95 | Experimental | Drug: HRS-9190 |
| Group B: Intravenous injection, 6×ED95 | Experimental | Drug: HRS-9190 |
| Group C: 2×ED95 (intravenous bolus) + intravenous infusion | Experimental | Drug: HRS-9190 |
| Group D: 2×ED95 (intravenous bolus) + intravenous infusion | Experimental | Drug: HRS-9190 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Before the trial, the subjects have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial. They can understand the procedures and methods of this study, are willing to strictly abide by the requirements of the entire clinical study, and voluntarily sign the informed consent form.
- Aged between 18 and 45 years (inclusive) at the time of signing the informed consent form, with both males and females eligible;
- ASA physical status classification of Class I;
- At the screening period, male subjects must weigh ≥50 kg, female subjects must weigh ≥45 kg, and the body mass index (BMI = weight (kg)/height² (m²)) is between 19 and 28 kg/m² (inclusive);
- Female subjects of childbearing potential must agree to use highly effective contraception and avoid donating eggs from the time of signing the informed consent form until 3 months after the last dose of the investigational product. Serum pregnancy tests at the screening and baseline periods must be negative, and they must not be breastfeeding. Male subjects whose partners are females of childbearing potential must agree to use highly effective contraception and avoid donating sperm from the time of signing the informed consent form until 3 months after the last dose of the investigational product.
Key exclusion criteria (24 listed)
- Subjects with a history or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic abnormalities, who are deemed unsuitable for enrollment by the investigator;
- Subjects with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism) or a history of poliomyelitis;
- Subjects with a history of anesthetic complications (such as a history of malignant hyperthermia or a family history of malignant hyperthermia, or those susceptible to malignant hyperthermia (patients with congenital diseases such as idiopathic scoliosis, strabismus, ptosis, umbilical hernia, inguinal hernia, etc.));
- Subjects with a history of asthma, a history of airway diseases requiring treatment or anatomical airway abnormalities, or signs of airway abnormalities assessed during screening airway examination that may affect laryngoscope insertion or tracheal intubation;
- During the screening or baseline period: subjects with clinically significant abnormal physical examination results as judged by the study doctor; subjects with clinically significant abnormal electrocardiograms or those with persistently/repeatedly QTcF > 450 ms in males and > 470 ms in females; subjects with hyperkalemia or hypokalemia that are judged by the investigator to be abnormal and clinically significant;
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-9190HRS-9190 | Drug | Group A: Intravenous injection, 3×ED95, Group B: Intravenous injection, 6×ED95, Group C: 2×ED95 (intravenous bolus) + intravenous infusion, Group D: 2×ED95 (intravenous bolus) + intravenous infusion |
Primary outcome
The incidence and severity of adverse events
Time frame: from ICF signing date to Day 7
Plasma histamine levels
Time frame: 10 minutes before midazolam administration and 40 minutes after administration
17 secondary outcomes
AUC0-t of HRS-9190
Time frame: 0 hour to 8 hour after administration
AUC0 inf of HRS-9190
Time frame: 0 hour to 8 hour after administration
Cmax of HRS-9190
Time frame: 0 hour to 8 hour after administration
Tmax of HRS-9190
Time frame: 0 hour to 8 hour after administration
t1/2 of HRS-9190
Time frame: 0 hour to 8 hour after administration
CL of HRS-9190
Time frame: 0 hour to 8 hour after administration
λz of HRS-9190
Time frame: 0 hour to 8 hour after administration
VZ of HRS-9190
Time frame: 0 hour to 8 hour after administration
VSS of HRS-9190
Time frame: 0 hour to 8 hour after administration
MRTinf of HRS-9190
Time frame: 0 hour to 8 hour after administration
AUC%Extrap of HRS-9190
Time frame: 0 hour to 8 hour after administration
The C-QTc relationship of HRS-9190.
Time frame: At least 90 minutes before the administration of midazolam to 24 hours after the administration of the investigational product
The maximum percentage of T1 suppression
Time frame: 0 hour to about 1 hour after the end of infusion
Onset time
Time frame: 0 hour to about 1 hour after the end of infusion
Duration of action
Time frame: 0 hour to about 1 hour after the end of infusion
Recovery time
Time frame: 0 hour to about 1 hour after the end of infusion
Recovery index
Time frame: 0 hour to about 1 hour after the end of infusion
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 28 Nov 2025.
- 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 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 5 inclusion and 24 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 28 Nov 2025. 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?
The incidence and severity of adverse events (time frame: from ICF signing date to Day 7). The study lists 2 primary outcomes in all. 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 28 Nov 2025.