general anesthesia
Conditions
Interventions
MFS-16 single bolus intravenous injection, dose-escalation group:iv bolus MFS-16
iv infusuion group:continuous iv infusion of MFS-16 for 1, 2 or 3 h
Placebo intravenous injection:Intravenous injection of saline or 10% glucose injection
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.age 18~45 yrs, Healthy adult men and women with full civil capacity; 2.body weight >=50 kg, body mass index 19~26 kg/m^2 (boundary values included); 3.understands the protocols of this trail, Willing to strictly follow the clinical trial protocol, to complete this trial and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Known allergy to benzodiazepines, flumazenil, anesthetics, or ingredients in the test drug formulations, or having medical conditions that are contraindications for such drugs; 2.Laboratory test results, vital signsphysical examination abnormalities and 12-ECG deemed clinically significant by the researcher; 3.Evidence of uncontrolled dysfunction in the liver, kidneys, central nervous system, respiratory system, cardiovascular system, or metabolism; 4.History of drug abuse within the last 3 months; or those who with positive results in drug abuse screening; 5.Those with a history of alcohol abuse/misuse for more than one week within the past three months, who cannot abstain from alcohol during the trial; 6.test positive for HBsAg, HCVAb, Syphilis antibody, or HIVAb; 7.Pregnant or breastfeeding women; 8.Mallampati>=? grade; 9.Any use of other prescription drugs, herbal medicines, over-the-counter drugs, or dietary supplements such as vitamins or calcium supplements within 2 weeks prior to screening; participants can only be enrolled if the principal investigator (PI) and the sponsor all determine that the medications used will not affect the safety of this trial or the PK/PD outcomes; 10.Individuals who have consumed excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) for a cumulative period of over one week within the past three months; 11.Those who smoked more than 5 cigarettes per day in the past 3 months and those who cannot abstain from smoking throughout the trial; 12.Those who have donated blood or blood lost =200 mL within 30 days before the trial; those who have donated plasma or undergone plasma exchange within 7 days before the trial; 13.Researchers believe that there is any situation that may affect participants' ability to provide informed consent or comply with the trial protocol, or where participants' participation in the trial may affect the trial results or their own safety, should be considered;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcomes: Vital signs, 12-lead ECG, physical examination, and laboratory tests, etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacology outcomes; | — |
Countries
China
Contacts
Public ContactYinQinqin
West China Hospital of Sichuan University
Outcome results
None listed