his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Mmanual IV bolus injection completed in 1 minute.
Apnea
No movement of chest wall and cessation of end-tidal carbon dioxide waveform \> 15 seconds.
Time frame: First dose of study drug on day 1
Safety by measurement of Adverse Events
Time frame: First dose of study drug on day 1
Modified observer's assessment of alertness/sedation(MOAA/S)
Observe the change of modified observer's assessment of alert /sedation during the whole trial
Time frame: From first dose of study drug until fully alert on day 1
Bispectral index (BIS)
Time frame: From first dose of study drug until fully alert on day 1
Median effective dose (ED50)
Time frame: From first dose of study drug until fully alert on day 1
Peak concentration (Cmax)
Time frame: From the start of administration to 48 hours after administration
Time to plasma peak concentration(Tmax)
Time frame: From the start of administration to 48 hours after administration
Terminal elimination half life (t1/2z) and mean residence time (MRT)
Time frame: From the start of administration to 48 hours after administration
Mean residence time (MRT)
Time frame: From the start of administration to 48 hours after administration
Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)
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Time frame: From the start of administration to 48 hours after administration
Total clearance (CL)
Time frame: From the start of administration to 48 hours after administration