The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Specified dose on specified day
Maximum plasma concentration (Cmax)
Time frame: Up to 28 days
Time to maximum plasma concentration (Tmax)
Time frame: Up to 28 days
Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
Time frame: Up to 28 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Time frame: Up to 28 days
Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
Time frame: Up to 28 days
Apparent first-order terminal elimination rate constant (Kel)
Time frame: Up to 28 days
Volume of distribution during the elimination phase after IV administration (Vz)
Time frame: Up to 28 days
Apparent volume of distribution at steady-state (Vss)
Time frame: Up to 28 days
Total plasma clearance of drug after IV administration (CL/F)
Time frame: Up to 28 days
Apparent first-order terminal elimination half-life (T1/2)
Time frame: Up to 28 days
Incidence of adverse events (AEs)
Time frame: Up to 28 days
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Incidence of serious adverse events (SAEs)
Time frame: Up to 28 days
Incidence of discontinuations of study drug due to toxicity
Time frame: Up to 28 days