A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.

Inclusion criteria

• Male, aged 18 - 49 years (inclusive).
• In general good health without clinically significant (CS) medical history.
• American Society of Anesthesiologists (ASA) Physical Status Classification of I or II.
• Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
• Negative screen for drugs of abuse, alcohol, Hepatitis B surface antigen (HBs-Ag), Hepatitis C Virus antibody (HCV-Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1.
• Normal or non-clinically significant (NCS) findings on a physical examination, 12-lead electrocardiogram (ECG) and vital signs (respiration rate between 12 and 20 breaths per minute, blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats per minute, temperature between 35.8°C and 37.5°C and pulse oximetry values > 95% on room air).
• Clinical laboratory values within the normal limits as defined by the clinical laboratory samples, unless the Principal Investigator (PI) decided that out-of-range values were not CS.
• Able to provide written informed consent.
• Willing and able to follow study instructions and likely to complete all study requirements.
• Suitable venous and arterial access.

Exclusion criteria

• History of allergy or sensitivity to: propofol, components of Fresofol 1% MCT/LCT propofol, or HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine.
• History of CS problems with general anesthesia.
• Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening.
• History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months.
• Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of simple analgesics such as paracetamol and oral non-steroidal antiinflammatory agents.
• Standard donation of blood within 30 days of the study.
• Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study.
• Receipt of any investigational study drug within 30 days prior to screening.
• Unable to fast for the 6 hours prior to Investigational Product administration.
• 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.
• Anticipated need for surgery or hospitalization during the study.
• Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia.