A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects

Inclusion criteria

• 1.Male, aged 18 - 49 years (inclusive)
• 2.Be in general good health without clinically significant medical history, as determined by the investigator
• 3.American Society of Anesthesiologists Physical Status Classification of I or II
• 4.Body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
• 5.Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1
• 6.Normal or non-clinically significant findings on a physical examination, 12-lead ECG and vital signs (respiration rate between 12 and 20 breaths per minute, BP between 100-140/50-90 mmHg, heart rate between 45-99 beats per minute, temperature between 35.8 degrees and 37.5 degrees). Pulse oximetry values >95% on room air.
• 7.Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the investigator decides that out-of-range values are not clinically significant
• 8.Ability to provide written informed consent
• 9.Willing and able to follow study instructions and likely to complete all study requirements
• 10.Suitable venous and arterial access.

Exclusion criteria

• 1.History of allergy or sensitivity to: propofol, etomidate or components of HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine
• 2.History of clinically significant problems with anesthesia induction
• 3.Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening
• 4.History of excessive alcohol intake (more than 4 standard drinks daily, on average) or use of recreational drugs within the last 3 months prior to screening
• 5.Intake of > 8 caffeine-containing drinks per day, on average, or approximately 800mg of caffenine daily on average; history of intolerance of abstinencce from caffeine for 3 days
• 6.Use of prescription or over the counter medications within 7 days of investigational product administration, with the exception of paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed the recommended daily dose), unless agreed as non-clinically relevant by the investigator and sponsor.
• 7.Standard donation of blood within 30 days of the study
• 8.Donation of plasma or participation in a plasmapheresis program within 7 days of investigational product administration
• 9.Receipt of any investigational study drug within 30 days prior to screening
• 10.Unable to fast for the 6 hours prior to investigational product administration
• 11.Clinically significant (as judged by the investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the clinical study unit
• 12.Anticipated need for surgery or hospitalization during the study
• 13.Craniofacial abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
• 14.History of seizures or epilepsy
• 15.History of ischaemic heart disease
• 16.History of brady- or tachy-dysrhythmias requiring medical care
• 17.History of asthma, with bronchospasm requiring treatment in the last 3 months
• 18.Any condition, which in the investigator's opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study
• 19.Receipt of HSK3486 less than 4 weeks prior to the start of the study.