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

NCT05701826 | Completed Phase 1

• 1 other identifier: HRS3797-103
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Skeletal Muscle Relaxation

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (1)

• The ED95 dosage

  0 minute to full neuromuscular recovery after administration

Study Arms (6)

Treatment group A1

EXPERIMENTAL

HRS3797 for injection

Drug: HRS3797

Treatment group A2

EXPERIMENTAL

HRS3797 for injection

Drug: HRS3797

Treatment group B1

EXPERIMENTAL

HRS3797 for injection

Drug: HRS3797

Treatment group B2

EXPERIMENTAL

HRS3797 for injection

Drug: HRS3797

Treatment group C1

EXPERIMENTAL

HRS3797 for injection

Drug: HRS3797

Treatment group C2

EXPERIMENTAL

HRS3797 for injection

Drug: HRS3797

Interventions

HRS3797 DRUG

HRS3797 for injection, low dose

Treatment group A1; Treatment group A2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS3797 for dose escalation

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: February 15, 2023
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

CN (1)