The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
Part A: Primary: To assess the safety and tolerability of single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects. Secondary: To assess the pharmacokinetics (PK) of FB418 and metabolite after single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects. To assess the effect of a high-fat meal on the PK of FB418 and metabolite after a single oral dose of FB418 when administered to healthy adult subjects. Part B: Primary: To assess the safety and tolerability of multiple ascending oral doses FB418 in healthy adult subjects. Secondary: To assess the PK of FB418 and metabolite after multiple ascending oral doses of FB418 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Oral dose
Seoul National University
Seoul, South Korea
RECRUITINGTreatment Emergent Adverse Events (TEAE)
Number of TEAEs including serious adverse events (SAEs)
Time frame: Up to 7 ~ 14 days after the last dose
PK parameter 1
Maximum observed concentration (Cmax) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 2
Time to maximum observed concentration (Tmax) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 3
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 4
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC\[0-last\]) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 5
Apparent terminal elimination half-life (t1/2) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
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