This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
71
Linear Clinical Research
Perth, Australia
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Maximum observed plasma concentration (Cmax)
Time frame: SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28
Time to maximum observed plasma concentration (Tmax)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal elimination rate constant
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal phase half-life (t1/2)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent total body clearance (CL/F)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent volume of distribution (Vz/F)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation.
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
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