This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
administrated orally
administrated orally
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Treatment-emergent adverse event
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Time frame: from baseline to day 37
Peak Plasma Concentration (Cmax)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 to 24 hours (AUC0-24)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: from day 1 to day 24
Time to maximum concentration (Tmax)
Time frame: from day 1 to day 24
Half-life (t1/2)
Time frame: from day 1 to day 24
ECG QTc Interval
Time frame: from baseline to day 37
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