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CompletedNCT05701826Updated Jun 7, 2023

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 in Healthy Subjects

A Phase 1 interventional study of HRS3797 and HRS3797 in Skeletal Muscle Relaxation, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-07.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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. To explore the ED95 dosage of HRS3797 in Chinese adults.

02

Conditions studied

  • Skeletal Muscle Relaxation
03

In context

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male and female subjects aged 18 to 45 years;
  2. Conform to the ASA I Physical Status Classification;
  3. 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);
  4. No pregnancy plan for the next 3 months and voluntary use of highly effective contraception during the trial;
  5. Able and willing to provide a written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Subjects with neuromuscular disease;
  3. Subjects with a history of anatomic airway abnormalities;
  4. Subjects with any known allergy history or specific allergic diseases (e.g., allergic asthma, urticaria, eczema, etc.);
  5. Subjects who underwent major surgery within 3 months prior to screening;
  6. 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;
  7. Subjects who received antihistamines or antidepressants within 3 months prior to screening;
  8. 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;
  9. Subjects who had used any medication within 14 days prior to administration;
  10. 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;
  11. 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;
  12. 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;
  13. 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;
  14. Subjects who consumed excessive amounts of tea, coffee, and caffeinated beverages within 3 months prior to the study;
  15. 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;
  16. Subjects who have special requirements for diet and cannot comply with a unified diet;
  17. The results of various examinations during the screening period were judged by the research doctor to be clinically significant abnormal;
  18. 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;
  19. Women who are pregnant or have a positive pregnancy test, or during breast-feeding;
  20. Subjects with positive alcohol expiratory test results;
  21. Subjects with positive smoking test results;
  22. Not suitable to be included in the study for other reasons as considered by investigators.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Treatment group A1

    HRS3797 for injection

    Drug: HRS3797

  • Experimental
    Treatment group A2

    HRS3797 for injection

    Drug: HRS3797

  • Experimental
    Treatment group B1

    HRS3797 for injection

    Drug: HRS3797

  • Experimental
    Treatment group B2

    HRS3797 for injection

    Drug: HRS3797

  • Experimental
    Treatment group C1

    HRS3797 for injection

    Drug: HRS3797

  • Experimental
    Treatment group C2

    HRS3797 for injection

    Drug: HRS3797

Interventions

  • DrugHRS3797

    HRS3797 for injection, low dose

  • DrugHRS3797

    HRS3797 for injection, medium dose

  • DrugHRS3797

    HRS3797 for injection, high dose

06

What researchers measure

Primary outcomes

  1. Maximum T1 Suppression

    Time frame: 0 minute to full neuromuscular recovery after administration

  2. Time to Maximum T1 Suppression

    Time frame: 0 minute to full neuromuscular recovery after administration

  3. The onset of neuromuscular block

    Time frame: 0 minute to full neuromuscular recovery after administration

  4. The duration of neuromuscular block

    Time frame: 0 minute to full neuromuscular recovery after administration

  5. The recovery rate of neuromuscular block

    Time frame: 0 minute to full neuromuscular recovery after administration

  6. Pharmacokinetic parameter of HRS3797: Cmax

    Time frame: 0 minute to 1.5 hour after administration

  7. Pharmacokinetic parameter of HRS3797: AUC0-t

    Time frame: 0 minute to 1.5 hour after administration

  8. Pharmacokinetic parameter of HRS3797: AUC0-∞

    Time frame: 0 minute to 1.5 hour after administration

  9. Pharmacokinetic parameter of HRS3797: Tmax

    Time frame: 0 minute to 1.5 hour after administration

  10. Pharmacokinetic parameter of HRS3797: t1/2z

    Time frame: 0 minute to 1.5 hour after administration

  11. Pharmacokinetic parameter of HRS3797: CLz

    Time frame: 0 minute to 1.5 hour after administration

  12. Pharmacokinetic parameter of HRS3797: Vz

    Time frame: 0 minute to 1.5 hour after administration

  13. The change of plasma histamine concentration from baseline

    Time frame: 0 minute to 1 hour after administration

  14. The incidence and severity of adverse events/serious adverse events

    Time frame: from ICF signing date to day 28

Secondary outcomes

  1. The ED95 dosage

    Time frame: 0 minute to full neuromuscular recovery after administration

07

Study locations

1 site
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 410013, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05701826
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 27, 2023
Start date
Feb 15, 2023
Primary completion
Jun 2, 2023
Completion
Jun 2, 2023
Last update
Jun 7, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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