This is a Phase Ib clinical study of TPN672 maleate in patients with schizophrenia
This is a single-center, randomized, double-blind, placebo-controlled, dosion-increasing, Phase Ib clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TPN672 maleate in patients with schizophrenia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
single dose of TPN-672 maleate tablet
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Adverse events
Incidence of Adverse Events
Time frame: follow-up visit from the beginning of the dose to the day 14 after the last dose
Blood pressure
Safety indicator,Blood pressure is recorded in millimeters of mercury
Time frame: Day 14
Respiration
Safety indicator,the unit of recording is the number of breaths per minute.
Time frame: Day 14
Heart rate
Safety indicator,the unit of heart rate is the number of heartbeats per minute.
Time frame: Day 14
Temperature
Safety indicator,Body temperature is recorded in degrees Celsius
Time frame: Day 14
Maximum plasma concentration (Cmax)
Blood will be drawn from adult subjects pre-drug application and at 30min, 60min, 90min, 120min, 180min, 240min (4h), 480min (8h),720min (12h),1440min(24h).
Time frame: 240 hours
Time to maximum plasma concentration (Tmax)
Biological sample including blood for PK will be collected at the same time point.
Time frame: 240 hours
Area under the curve (AUC)
Biological sample including blood for PK will be collected at the same time point.
Time frame: 240 hours
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steady state minimal concentration(Css_min)
Biological sample including blood for PK will be collected at the same time point
Time frame: 240hours
Elimination half-life (t1/2)
Biological sample including blood for PK will be collected at the same time point.
Time frame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours ,days 8-14 after the last dose.
Positive and Negative Syndrome Scale
The PANSS consisted of a positive scale of 7 items, a negative scale of 7 items, and a general psychopathology scale of 16 items, for a total of 30 items, and 3 supplementary items to assess the risk of attack. A 7-point scale with increasing levels of psychopathology was used: 1 nothing; 7 a very severe.
Time frame: Follow-up visit on the day 14 after the last dose
Clinical Global Impression sions scale
The scale is divided into 1. overall assessment of disease severity 2. overall degree of improvement. The lower the score, the higher the degree of improvement of the patient.
Time frame: Follow-up visit on the day 14 after the last dose
Calgary Depression Scale for Schizophrenia
There were 9 entries, including mood depression, feelings of hopelessness, self-deprecation, guilt implicated perceptions, pathological guilt, morning depression, early awakening, suicidality, and observed depressive manifestations. The lower the score the less severe the depressive symptoms.
Time frame: Follow-up visit on the day 14 after the last dose
Blood coagulation function
Safety indicators, including PT,APTT
Time frame: Day 14
12-lead ECG
Safety indicators, including QTc
Time frame: Day 14
Serum prolactin ( PRL)
Testing for affected hormone levels
Time frame: Day 14