None
Conditions
Interventions
Group A2:Group A2: Three subjects were included and received 0.03 mg/kg injectable HRS-9190, allowing for discretionary dose adjustment based on data from Grou
Group D:The ED90 and ED95 doses were re-estimated based on the dose-response of subjects in the A-C group. Six subjects were included, each receiving two dose
Group C:The ED50 and ED90 doses were re-estimated based on the dose-response responses of subjects in the A-B group. Six subjects were included and received t
Group E:According to the data of all the subjects in the four groups A-D, the dose-effect relationship model was established to estimate the human ED95 dose.
Group B:ED25 and ED75 doses were estimated based on dose-response responses in Group A. Six subjects were included and received two doses of ED25 and ED75, re
Group A1:Group A1: Three subjects were included and received 0.01 mg/kg injectable HRS-9190. If no pharmacodynamic response was observed in the first subject,
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The age of signing the informed consent is between 18 and 45 years old (including the boundary value), both male and female; 2. ASA grade is I-II; 3. During the screening period, male body weight >=50 kg, female body weight>=45 kg, body mass index (BMI = weight (kg)/ height^ 2(m^2)) between 19 and 28 kg/m^2 (including boundary value); 4. Fertile female subjects must agree to highly effective contraception and refrain from egg donation from signing the informed consent until 3 months after the last administration of the experimental drug, the serum pregnancy test during the screening period and the baseline period must be negative, and they are not lactating; Male subjects whose partner is a fertile woman must agree to highly effective contraception and refrain from sperm donation from signing the informed consent until 3 months after the final administration of the investigational drug (see Section 13.1 for details); 5. The subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks and discomfort of the trial before the trial, can understand the procedures and methods of the study, are willing to strictly abide by the requirements of the entire clinical study, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, metabolic and other clinical acute and chronic diseases who were determined by the researchers to be unsuitable for inclusion; 2. People with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism) or poliomyelitis; 3. Patients with a history of anesthesia complications; 4. Patients with a history of asthma or airway diseases requiring treatment; 5. Patients with a history of anatomic airway abnormalities or signs of airway abnormalities assessed during screening airway examinations that may affect laryngoscope placement or tracheal intubation; 6. Patients with a history or family history of malignant hyperthermia, or who are susceptible to malignant hyperthermia (congenital diseases such as idiopathic scoliosis, strabismus, ptosis, umbilical hernia, inguinal hernia, etc.); 7. Screening period or baseline period: patients with aspartate aminotransferase, alanine aminotransferase, total bilirubin, blood creatinine exceeding the upper limit of the normal range, patients with QTcF > 450 ms, or patients with abnormal and clinically significant hyperkalemia or hypokalemia determined by researchers; 8. People with known allergic history to the investigational drug or excipients of the investigational drug, or allergic constitution (allergic to two or more drugs and food); 9. Patients who underwent major surgery within 6 months prior to screening, or who had prior surgery that could significantly affect the pharmacokinetic profile or safety evaluation of the study drug (e.g., liver or kidney transplantation), or who planned to undergo surgery during the trial; 10. Any drugs that inhibit or induce liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) have been used within 1 month before administration; Inhibitors - SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 11. Those who received antihistamines or antidepressants within 3 months prior to screening; 12. Those who were vaccinated within 1 month prior to screening or planned to be vaccinated during the trial; 13. People who have used any drug or health product (including Chinese herbal medicine) within 7 half-lives or 14 days (whichever is longer) prior to administration, or who may require additional drug treatment during the known screening period of the test; 14. Participants who have participated in a clinical trial and received the investigational drug within 3 months prior to screening, or who plan to participate in other clinical trials during the trial; 15. People who donate/lose =400 mL of blood (except for female physiologic blood loss) in the 3 months prior to screening, receive blood transfusions or use blood products, or plan to donate blood during the trial or within 1 month after the trial ends; 16. Those who smoked more than 5 cigarettes per day on average in the 3 months before screening, or could not quit smoking during the trial period; 17. Those who consumed an average of more than 14 units of alcohol per week in the three months prior to screening (1 unit ˜285 mL of beer with 3.5% alcohol, or 25 mL of spirits with 40% alcohol, or 85 mL of wine with 12% alcohol), or did not agree to abstinence during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examination;12-lead electrocardiogram examination;Plasma histamine levels;Vital sign;ECG monitoring;Laboratory examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics;pharmacodynamics; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed