This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection. Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Safety by measurement of Adverse Events
Time frame: First dose of study drug 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)
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
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