This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and vomiting potential and adrenal suppression (etomidate). All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the study unit from the evening of Day -1 until the morning of Day 2, then will be required to return for a follow up visit on Day 7. Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Safety by measurement of Adverse Events
Time frame: on day 1 until 24 hours post-dose
Richmond Agitation Sedation Scale (RASS)
* 0 Alert and calm * 1 Not fully alert, but has sustained awakening (eyeopening/eye contact) to voice (≥ 10 seconds) * 2 Briefly awakens with contact to voice (\< 10 seconds) * 3 Movement or eye opening to voice (but no eye contact) * 4 No response to voice, but movement or eye opening to physical stimulation * 5 No response to voice or physical stimulation
Time frame: First dose of study drug on day 1
bispectral index (BIS)
Time frame: First dose of study drug on day 1
subject-rated Quality of Recovery Assessment (QoR-9)
Time frame: First dose of study drug on day 1
Peak concentration (Cmax)
Time frame: on day 1 until 24 hours post-dose
Time to plasma peak concentration(Tmax)
Time frame: on day 1 until 24 hours post-dose
Area Under the Curve
Time frame: on day 1 until 24 hours post-dose
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