This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Beijing AnDing Hospital Capital Medical University
Beijing, China
RECRUITINGNumber of participants with adverse events (AEs) and serious adverse events (SAEs).
Time frame: up to Day 11
Number of participants with clinical laboratory assessment abnormalities.
Time frame: up to Day 11
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 11 of subjects with stable schizophrenia
The total score range is 30 to 210.A higher score is associated with greater illness severity.
Time frame: up to Day 11
Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) at Day 11 of subjects with stable schizophrenia
This scale is divided into three parts, which are evaluated suicidal ideation(5 items \[yes/no\]),intensity of ideation (5 items on 5-point scales; scores range from 0 to 25 with higher scores indicating more intense suicidal ideation),and suicide behavior(actual attempt,interrupted attempt,aborted attempt, preparatory acts or behavior).
Time frame: up to Day 11
Change from Baseline in Barnes Akathisia Rating Scale (BARS) at Day4 and Day 11 of subjects with stable schizophrenia
The total score range is 0 to 14.A higher score is associated with greater illness severity.
Time frame: up to Day 11
Change from Baseline in Simpson-Angus Scale (SAS) at Day4 and Day 11 of subjects with stable schizophrenia
This scale consists of 10 items, and each question is scored from 0 to 4 points. The Total score range is 0 to 40.A higher score is associated with greater illness severity.
Time frame: up to Day 11
Maximum observed concentration at steady state (Cmax,ss) of LPM787000048 in plasma
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Time frame: up to Day 11
Minimum observed concentration at steady state (Cmin,ss) of LPM787000048 in plasma
Time frame: up to Day 11
Area under the concentration- time curve during the dosing interval at steady state (AUC0-τ,ss) of LPM787000048 in plasma
Time frame: up to Day 11
Area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM787000048 in plasma
Time frame: up to Day 11
Time to maximum observed concentration at steady (Tmax,ss) state of LPM787000048 in plasma
Time frame: up to Day 11
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
Time frame: up to Day 11
AUC Accumulation Ratio (Ra(AUC)) of LPM787000048 in plasma
Time frame: up to Day 11
Cmax Accumulation Ratio (Ra(Cmax)) of LPM787000048 in plasma
Time frame: up to Day 11
Number of participants with vital sign abnormalities.
Time frame: up to Day 11
Number of participants with 12-lead electrocardiogram abnormalities (ECGs).
Time frame: up to Day 11
Number of participants with ophthalmic examination abnormalities.
Time frame: up to Day 11