None
Conditions
Interventions
Group 1:0.04 mg/kg (Including 2 cases of placebo):On the morning of D1, before administration, the subjects' weight after emptying urine was measured on an empty stomach. The dosage was calculated bas
Group 2:0.08 mg/kg(including 2 placebo cases and 2 positive controls):On the morning of D1, before the administration of the drug, the body weight after emptying urine was measured on an empty stomach
Group 3:0.16 mg/kg(including 2 placebo cases and 2 positive controls):On the morning of D1, before the administration of the drug, the body weight after emptying urine was measured on an empty stomach
Group 4:0.24 mg/kg(including 2 placebo cases and 2 positive controls):On the morning of D1, before the administration of the drug, the body weight after emptying urine was measured on an empty stomach
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who, after fully understanding the purpose, content, process and possible risks of the trial, voluntarily participate and sign the informed consent form; 2. Healthy male or female subjects aged 18 to 45 years (including the cut-off value) at the time of signing the informed consent form; 3. Male subjects should weigh no less than 50.0 kg, and female subjects should weigh no less than 45.0 kg. The body mass index (BMI) is within the range of 19.0 to 26.0 kg/m^20 (including the critical value). 4. Within 3 months from the signing of the informed consent form to the end of the infusion and administration of the investigational drug, the subject (and his/her partner) has no plans for having children, the subject has no plans for sperm or egg donation, and voluntarily takes effective contraceptive measures within 3 months after the end of the infusion and administration of the investigational drug; 5. Be able to communicate well with the researcher, be willing and able to abide by the lifestyle restrictions stipulated in the protocol, and cooperate to complete the experimental process.
Exclusion criteria
Exclusion criteria: 1.Those with a history of cardiovascular, endocrine, respiratory, digestive, urinary, nervous, hematological and/or lymphatic systems, as well as a history of mental illness, and who are considered by the researchers to still have clinical significance at the time of screening; 2. Those who have a history of anesthesia accidents, serious adverse reactions to anesthesia, or a family history of anesthesia accidents before screening; 3. Those who had ventilation difficulties before screening or were suspected of having difficult airways or were estimated to have difficulty in tracheal intubation (such as modified Mall-ampti score grade III-IV, congenital ovulatory and lingual hypertrophy, mandibular dysplasia, etc.); 4. Those with a history of airway diseases such as bronchial asthma, chronic obstructive pulmonary disease, and sleep apnea syndrome before or during screening; 5. Those with a history of adrenal cortical insufficiency, adrenal tumors, hereditary heme biosynthesis disorders, or hereditary acute porphyria before or during screening; 6. Those with abnormal results in physical examination, vital signs, full chest X-ray, abdominal B-ultrasound examination, and laboratory tests [blood routine, urine routine, blood biochemistry, coagulation function, and four items of blood transfusion] and with clinical significance, or those determined by the researcher to have abnormal overall rhythm of cortisol and/or ACTH and with clinical significance; 7. During screening, individuals with clinically significant electrocardiogram abnormalities were identified, such as QTcF>= 450 ms (for males) or >=460 ms (for females), etc. 8. Those who test positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and Treponema pallidum antibody (TP-Ab); 9. Women who are pregnant or breastfeeding during the screening period, or women of childbearing age with positive pregnancy results; 10. Those who have a history of drug abuse or drug dependence within one year prior to screening, or who test positive in urine drug screening at the time of screening; 11. Those who have a history of alcohol abuse within 6 months prior to screening [i.e., drinking more than 14 standard units per week (1 unit =360 ml of beer or 45 ml of 40% alcohol or 150 ml of wine)], or have a positive breath test for alcohol during screening, or are unwilling to stop drinking alcohol or any alcoholic products during the test period; 12. Those who were heavy smokers (smoking at least 5 cigarettes per day) within 6 months prior to screening, or who were unwilling to stop using any tobacco products during the trial period, or who tested positive for tobacco during screening; 13. Those who consumed excessive amounts (more than 8 cups, 1 cup =250 ml) of tea, coffee or caffeinated beverages (such as milk tea, cola, etc.) every day before screening, or those who were unwilling to stop drinking the above-mentioned beverages during the trial period; 14. Those who have used any medications within 14 days prior to screening, including prescription drugs, over-the-counter drugs, traditional Chinese medicine, health supplements and vitamins; 15. Those who are known to be allergic to etomimide or other anesthetic drugs, or have an allergic constitution (such as being allergic to two or more drugs, foods or pollen), or have a constitution prone to rashes, urticaria, etc., or have a history of allergic diseases, or are known to be aller
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram indicators ;Vital signs;Plasma cortisol and adrenocorticotropic hormone (ACTH) concentrations; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Indicators; | — |
Countries
China
Contacts
Public ContactYang Guoping; Wang Saiying
The Third Xiangya Hospital, Central South University
Outcome results
None listed