A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia
This study adopts a multi-center, randomized, double-blind, dose-increasing, parallel-control titration drug delivery study design. Preset three dose groups (S1, S2, S3), low, medium and high, with target doses of 1.5mg, 3mg and 6mg respectively. Each dose group included 20 subjects (16 patients received the test drug and 4 patients received placebo). During the test, observe the safety and tolerance of the subjects, and collect PK blood samples. Schizophrenic patients who met the inclusion criteria after screening and evaluation were randomly enrolled on the baseline day. On the first administration day, all dose groups took 1.5mg as the starting dose. Each subject should closely observe the tolerance and safety within 24 hours after the first administration. Only when the investigator evaluated it as tolerable, can the subsequent multiple administration be continued.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Incidence of treatment-emergent adverse events (TEAEs)
The number and percentage of participants with TEAEs will be determined
Time frame: Day1 to Day 28
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 28
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time frame: Day1 to Day 28
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Day 28
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time frame: Day1 to Day 28
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Day 28
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time frame: Day1 to Day 28
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
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Time frame: Day1 to Day 28
Tmax
Peak time
Time frame: Day1 to Day 28
Css_min
Steady-state trough concentration
Time frame: Day1 to Day 28
Css_max
Steady-state peak concentration
Time frame: Day1 to Day 28
Css_av
Mean steady-state blood drug concentration
Time frame: Day1 to Day 28
AUC0-t,ss
Area under the plasma concentration-time curve from the last dose to the last measurable concentration time point
Time frame: Day1 to Day 28
AUC0-∞,ss
Extrapolated area under the plasma concentration-time curve from the last dose to infinity
Time frame: Day1 to Day 28
AUCtau,ss
Area under the plasma concentration-time curve within one dosing interval at steady state
Time frame: Day1 to Day 28
t1/2
Elimination half-life
Time frame: Day1 to Day 28