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

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701826

Collaborator

(none)

Enrollment

Arms

4.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Skeletal Muscle Relaxation	Drug: HRS3797 Drug: HRS3797 Drug: HRS3797	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

HRS3797 for dose escalationHRS3797 for dose escalation

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dose Escalation Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 After Intravenous Infusion Administration in Healthy Adults

Anticipated Study Start Date :

Feb 25, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group A1 HRS3797 for injection	Drug: HRS3797 HRS3797 for injection, low dose
Experimental: Treatment group A2 HRS3797 for injection	Drug: HRS3797 HRS3797 for injection, low dose
Experimental: Treatment group B1 HRS3797 for injection	Drug: HRS3797 HRS3797 for injection, medium dose
Experimental: Treatment group B2 HRS3797 for injection	Drug: HRS3797 HRS3797 for injection, medium dose
Experimental: Treatment group C1 HRS3797 for injection	Drug: HRS3797 HRS3797 for injection, high dose
Experimental: Treatment group C2 HRS3797 for injection	Drug: HRS3797 HRS3797 for injection, high dose

Outcome Measures

Primary Outcome Measures

Maximum T1 Suppression [0 minute to full neuromuscular recovery after administration]
Time to Maximum T1 Suppression [0 minute to full neuromuscular recovery after administration]
The onset of neuromuscular block [0 minute to full neuromuscular recovery after administration]
The duration of neuromuscular block [0 minute to full neuromuscular recovery after administration]
The recovery rate of neuromuscular block [0 minute to full neuromuscular recovery after administration]
Pharmacokinetic parameter of HRS3797: Cmax [0 minute to 1.5 hour after administration]
Pharmacokinetic parameter of HRS3797: AUC0-t [0 minute to 1.5 hour after administration]
Pharmacokinetic parameter of HRS3797: AUC0-∞ [0 minute to 1.5 hour after administration]
Pharmacokinetic parameter of HRS3797: Tmax [0 minute to 1.5 hour after administration]
Pharmacokinetic parameter of HRS3797: t1/2z [0 minute to 1.5 hour after administration]
Pharmacokinetic parameter of HRS3797: CLz [0 minute to 1.5 hour after administration]
Pharmacokinetic parameter of HRS3797: Vz [0 minute to 1.5 hour after administration]
The change of plasma histamine concentration from baseline [0 minute to 1 hour after administration]
The incidence and severity of adverse events/serious adverse events [from ICF signing date to day 28]

Secondary Outcome Measures

The ED95 dosage [0 minute to full neuromuscular recovery after administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Shengdi Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05701826

Other Study ID Numbers:

HRS3797-103

First Posted:

Jan 27, 2023

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 27, 2023