This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
62
single dose of TPN-672 maleate tablet
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGAdverse events
Number of Subjects with adverse events during clinical trial
Time frame: 48 hours
Cmax
Maximum Plasma Concentration
Time frame: 48 hours
AUC
Area Under the Curve
Time frame: 48 hours
Tmax
Time to Cmax
Time frame: 48 hours
T1/2
Time of half life
Time frame: 48 hours
ACR
Apparent Clearance Rate
Time frame: 48 hours
ADV
Apparent Distribution Volume
Time frame: 48 hours
prolactin
serum prolactin test
Time frame: 48 hours
temperature
ear temperature
Time frame: 48 hours
pulse rate
pulse rate
Time frame: 48 hours
respiratory
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frequency of respiratory per minute
Time frame: 48 hours
blood pressure
lying blood pressure, systolic and diastolic
Time frame: 48 hours
electrocardiogram(ECG)
the number of subjects with abnormal ECG report by 12-lead electrocardiogram
Time frame: 48 hours
QTc
QTc interval
Time frame: 48 hours
Extrapyramidal symptoms
Simpson Angus Rating Scale (SAS), total score ranges from 0 to 40, of which lower values represent a better outcome.
Time frame: 48 hours
Involuntary Movement
Abnormal Involuntary Movement Scale (AIMS), total score ranges from 0 to 14, of which lower values represent a better outcome.
Time frame: 48 hours
Akathisia
Barnes Akathisia Rating Scale (BARS), total score ranges from 0 to 40, of which lower values represent a better outcome.
Time frame: 48 hours
IL-6
Serum concentration of Interleukin-6
Time frame: 48 hours
IL-4
Serum concentration of Interleukin-4
Time frame: 48 hours
IL-1
Serum concentration of Interleukin-1
Time frame: 48 hours
IL-2
Serum concentration of Interleukin-2
Time frame: 48 hours
INF-gamma
Serum concentration of Interferon-gamma
Time frame: 48 hours
TNF-alpha
Serum concentration of Tumor necrosis factor-alpha
Time frame: 48 hours
5-HT
Serum concentration of serotonin
Time frame: 48 hours
DA
Serum concentration of Dopamine
Time frame: 48 hours
NE
Serum concentration of Norepinephrine
Time frame: 48 hours
BDNF
Serum concentration of Brain-derived neurotrophic factor
Time frame: 48 hours
Glutamic acid
Serum concentration of Glutamic acid
Time frame: 48 hours
GABA
Serum concentration of gamma-aminobutyric acid
Time frame: 48 hours