This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation 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 subsequent clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
LPM3770164 sustained release tablet will be administrated orally single-dose on day 1
LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Treatment-emergent adverse effects
Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Time frame: from baseline to day 28
Maximum observed concentration (Cmax)
Time frame: from baseline to day 15
Time to maximum observed concentration (Tmax)
Time frame: from baseline to day 15
Area under the concentration-time curve (AUC)
Time frame: from baseline to day 15
Clearance (CL)
Time frame: from baseline to day 15
Half-life (t1/2)
Time frame: from baseline to day 15
Mean Residence Time (MRT)
Time frame: from baseline to day 15
Haematology
Time frame: baseline, day 3, day 8, day 15, day 28
Blood Chemistry
Time frame: baseline, day 3, day 8, day 15, day 28
Urinalysis
Time frame: baseline, day 15, day 28
Coagulation
Time frame: baseline, day 15, day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Body Temperature
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Respiratory Rate
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Blood Pressure
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Pulse Rate
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Physical Examination
Time frame: baseline, day 15, day 28
12 lead electrocardiogram corrected QT interval
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Simpson-Angus Rating Scale (SAS)
Time frame: baseline, day 3, day 28
Barnes Akathisia Rating Scale (BARS)
Time frame: baseline, day 3, day 28
Abnormal Involuntary Movement Scale (AIMS)
Time frame: baseline, day 3, day 28
Stanford Sleepiness Scale (SSS)
Time frame: baseline, day 3, day 28