Skeletal Muscle RelaxationPhase 1NCT05701826
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 in Healthy Subjects
A Phase 1 study testing HRS3797 in people with Skeletal Muscle Relaxation, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. 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?
- HRS3797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 2 Jun 2023
- 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;
- Conform to the ASA I Physical Status Classification;
- Male subjects weighed ≥ 50kg, female subjects weighed ≥ 45kg, and body mass index (BMI) was in the range of 19.0~26.0 kg/m2 (inclusive);
- No pregnancy plan for the next 3 months and voluntary use of highly effective contraception during the trial;
- Able and willing to provide a written informed consent.
Who cannot join
- Subjects with any clinically serious disease, such as circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic abnormalities, that may affect the pharmacokinetic characteristics or safety evaluation of the investigational drug as determined by the investigator;
- Subjects with neuromuscular disease;
- Subjects with a history of anatomic airway abnormalities;
- Subjects with any known allergy history or specific allergic diseases (e.g., allergic asthma, urticaria, eczema, etc.);
- Subjects who underwent major surgery within 3 months prior to screening;
- Subjects who underwent surgery that could significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or who planned to undergo surgery during the study period;
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- Subjects who received antihistamines or antidepressants within 3 months prior to screening;
- Subjects who used any drug that inhibits or induces liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration;
- Subjects who had used any medication within 14 days prior to administration;
- Subjects who took other investigational drugs or used investigational devices within 3 months prior to the screening, or who planned to participate in other clinical trials during the study period;
- Subjects who donated blood or suffered massive blood loss of >= 400 mL (except for physiological blood loss in women), received blood transfusions or used blood products within 3 months prior to the study, or planned to donate blood during the study period or within 1 month after finishing the study;
- Subjects who smoked more than 5 cigarettes per day on average within 3 months prior to the study, or who could not quit smoking during the study period;
- Subjects had a history of alcohol abuse within 3 months prior to the study, i.e., an average of more than 14 units of alcohol per week;
- Subjects who consumed excessive amounts of tea, coffee, and caffeinated beverages within 3 months prior to the study;
- Subjects who consumed special diet (e.g., grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine, etc.) within 48 hours before administration;
- Subjects who have special requirements for diet and cannot comply with a unified diet;
- The results of various examinations during the screening period were judged by the research doctor to be clinically significant abnormal;
- Subjects who have one or more positive test results for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody;
- Women who are pregnant or have a positive pregnancy test, or during breast-feeding;
- Subjects with positive alcohol expiratory test results;
- Subjects with positive smoking test results;
- Not suitable to be included in the study for other reasons as considered by investigators.
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: Dose Escalation Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 After Intravenous Infusion Administration in Healthy Adults
This is a single-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.
- Conditions
- Skeletal Muscle Relaxation
- Being tested
- HRS3797
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS3797Drug
HRS3797 for injection, low dose
HRS3797Drug
HRS3797 for injection, medium dose
HRS3797Drug
HRS3797 for injection, high dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A1 | Experimental | HRS3797 for injection Receives: Drug: HRS3797 |
| Treatment group A2 | Experimental | HRS3797 for injection Receives: Drug: HRS3797 |
| Treatment group B1 | Experimental | HRS3797 for injection Receives: Drug: HRS3797 |
| Treatment group B2 | Experimental | HRS3797 for injection Receives: Drug: HRS3797 |
| Treatment group C1 | Experimental | HRS3797 for injection Receives: Drug: HRS3797 |
| Treatment group C2 | Experimental | HRS3797 for injection Receives: Drug: HRS3797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum T1 Suppression
Measured: 0 minute to full neuromuscular recovery after administration
Time to Maximum T1 Suppression
Measured: 0 minute to full neuromuscular recovery after administration
The onset of neuromuscular block
Measured: 0 minute to full neuromuscular recovery after administration
The duration of neuromuscular block
Measured: 0 minute to full neuromuscular recovery after administration
The recovery rate of neuromuscular block
Measured: 0 minute to full neuromuscular recovery after administration
Pharmacokinetic parameter of HRS3797: Cmax
Measured: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-t
Measured: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-∞
Measured: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Tmax
Measured: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: t1/2z
Measured: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: CLz
Measured: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Vz
Measured: 0 minute to 1.5 hour after administration
The change of plasma histamine concentration from baseline
Measured: 0 minute to 1 hour after administration
The incidence and severity of adverse events/serious adverse events
Measured: from ICF signing date to day 28
Secondary outcomes (1)
The ED95 dosage
Measured: 0 minute to full neuromuscular recovery after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start15 Feb 2023
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
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 Fujian Shengdi Pharmaceutical 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- HRS3797 for dose escalation
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701826
- Sponsor's protocol ID
- HRS3797-103
- Status last verified
- Jun 2023
- First submitted
- 18 Jan 2023
- Last updated
- 7 Jun 2023
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 After Intravenous Infusion Administration in Healthy Adults
- ClinicalTrials.gov ID
- NCT05701826
- Acronym / sponsor ID
- HRS3797-103
- Conditions
- Skeletal Muscle Relaxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 27 Jan 2023 (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, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- HRS3797 for dose escalation
| Arm | Type | Receives |
|---|---|---|
| Treatment group A1 | Experimental | Drug: HRS3797HRS3797 for injection |
| Treatment group A2 | Experimental | Drug: HRS3797HRS3797 for injection |
| Treatment group B1 | Experimental | Drug: HRS3797HRS3797 for injection |
| Treatment group B2 | Experimental | Drug: HRS3797HRS3797 for injection |
| Treatment group C1 | Experimental | Drug: HRS3797HRS3797 for injection |
| Treatment group C2 | Experimental | Drug: HRS3797HRS3797 for injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects aged 18 to 45 years;
- Conform to the ASA I Physical Status Classification;
- Male subjects weighed ≥ 50kg, female subjects weighed ≥ 45kg, and body mass index (BMI) was in the range of 19.0~26.0 kg/m2 (inclusive);
- No pregnancy plan for the next 3 months and voluntary use of highly effective contraception during the trial;
- Able and willing to provide a written informed consent.
Key exclusion criteria (22 listed)
- Subjects with any clinically serious disease, such as circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic abnormalities, that may affect the pharmacokinetic characteristics or safety evaluation of the investigational drug as determined by the investigator;
- Subjects with neuromuscular disease;
- Subjects with a history of anatomic airway abnormalities;
- Subjects with any known allergy history or specific allergic diseases (e.g., allergic asthma, urticaria, eczema, etc.);
- Subjects who underwent major surgery within 3 months prior to 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 |
|---|---|---|
| HRS3797HRS3797 for injection, low dose | Drug | Treatment group A1, Treatment group A2 |
| HRS3797HRS3797 for injection, medium dose | Drug | Treatment group B1, Treatment group B2 |
| HRS3797HRS3797 for injection, high dose | Drug | Treatment group C1, Treatment group C2 |
Primary outcome
Maximum T1 Suppression
Time frame: 0 minute to full neuromuscular recovery after administration
Time to Maximum T1 Suppression
Time frame: 0 minute to full neuromuscular recovery after administration
The onset of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
The duration of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
The recovery rate of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
Pharmacokinetic parameter of HRS3797: Cmax
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-t
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-∞
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Tmax
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: t1/2z
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: CLz
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Vz
Time frame: 0 minute to 1.5 hour after administration
The change of plasma histamine concentration from baseline
Time frame: 0 minute to 1 hour after administration
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to day 28
1 secondary outcome
The ED95 dosage
Time frame: 0 minute to full neuromuscular recovery 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 7 Jun 2023.
- Individual participant dataSharing planned: Undecided
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 HRS3797 in people with Skeletal Muscle Relaxation, run by Fujian Shengdi Pharmaceutical 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 22 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 7 Jun 2023. 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?
Maximum T1 Suppression (time frame: 0 minute to full neuromuscular recovery after administration). The study lists 14 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 7 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.