This is a phase 1,randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects
Primary: To assess the safety and tolerability of multiple oral doses of LY03017 in healthy adult subjects. Secondary: To assess the pharmacokinetics (PK) of LY03017 after multiple oral doses of LY03017 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
administered orally
administered orally
Shanghai Mental Health Center
Shanghai, China
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to day 9
Maximum observed concentration at steady state (Cmax,ss) of LPM526000133 in plasma
Time frame: up to day 9
Time to maximum observed concentration at steady state (Tmax,ss) of LPM526000133 in plasma
Time frame: up to day 9
Minimum observed concentration at steady state (Cmin,ss) of LPM526000133 in plasma
Time frame: up to day 9
Area Under the Concentration-Time Curve from Time Zero to Tau over a Dosing Interval at Steady State(AUC0-τ,ss)of LPM526000133 in plasma
Time frame: up to day 9
The area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM526000133 in plasma
Time frame: up to day 9
Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma
Time frame: up to day 9
Accumulation ratio (Ra) of LPM526000133 in plasma
Time frame: up to day 9
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