None listed
Conditions
Interventions
Group A:10 received HRS3797 and 2 received placebo (0.9% sodium chloride injection) at 0.74 mg/kg
Group B:Twelve patients received HRS3797 and two received placebo (0.9% sodium chloride injection) at a dose of 1.11 mg/kg
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years (including the boundary value), no gender limit; 2. ASA classification is Class I; 3. Male weight >= 50 kg, female weight >= 45 kg, body mass index (BMI) between 19.0 - 26.0 kg/m^2 (including boundary values); 4. Volunteers have no plans to donate sperm or eggs within 3 months after signing the informed consent form, and voluntarily use efficient and reliable contraceptive methods to avoid pregnancy of female volunteers or pregnancy of male volunteer partners; 5. Volunteers have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks and discomforts of the trial before the trial, be able to understand the procedures and methods of this study, be willing to strictly abide by the requirements of the entire clinical study, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous or current clinical acute and chronic diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, those who have been judged by the investigator to have a significant impact on the pharmacokinetic characteristics or safety evaluation of the investigational drug; 2. Those with a history of neuromuscular diseases (such as myotonic dystrophy, polio, myasthenia gravis, botulism) or poliomyelitis; 3. Those with a history of anesthesia complications; 4. Those with a history of asthma or airway diseases requiring treatment; 5. Those who have a history of anatomical airway abnormalities, or have signs of airway abnormalities assessed during screening airway examinations, which may affect laryngoscope placement or tracheal intubation; 6. Those with a history or 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.); 7. Those who have any history of allergies in the past, or those who have specific allergic diseases (such as allergic asthma, urticaria, eczema, etc.); 8. Those who have undergone major surgery within 3 months (90 days) before screening; 9. Those who have undergone surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or those who plan to undergo surgery during the study period; 10. Those who have received antihistamines or antidepressants within 3 months (90 days) before screening; 11. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before administration (eg: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitorsSSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 12. Those who have been vaccinated within 30 days before administration; 13. Those who have used any drugs or health products (including Chinese herbal medicine) within 14 days before administration; 14. During the screening period, it is known that other drug treatment may be required during the research period; 15. Those who have used any clinical research drugs within 3 months (90 days) before screening, or plan to participate in other clinical trials during this study; 16. Those who donated blood/blood loss >=400 mL within 3 months (90 days) before screening (excluding physiological blood loss in women), received blood transfusion or used blood products, or planned to donate blood during the trial or within 1 month after the end of the trial; 17. Those who smoked more than 5 cigarettes on average per day within 3 months (90 days) before screening, or who could not quit smoking during the trial; 18. Frequent drinkers within 3 months (90 days) prior to screening (average weekly drinking of more than 14 units of alcohol, 1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or those who could not stop drinking during the trial; 19. Those who drank excessive tea, coffee or caffeinated beverages (average more than 8 cups per day, 1 cup = 200 mL) within 3 months (90 days) before screening; 20. Those who consume special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactOuyang Wen, Yang Guoping
The Third Xiangya Hospital of Central South University
Outcome results
None listed