Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2 Subjects with Stable Schizophrenia
Subjects themselves and / or their guardians sign informed consent voluntarily.
Male or female aged 18 to 60 years.
Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 32.0 kg/m2.
Subject must meet the DSM-V criteria for a primary diagnosis of schizophrenia. Subject must have a PANSS total score ≤ 80 and CGI-S score ≤ 4 at screening. The condition is stable from 1 month before signing informed consent to baseline.
You may not be if
Healthy Subjects
Subjects have any clinically significant medical condition or chronic disease.
Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
Subjects with a history of orthostatic hypotension or syncope.
Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation
Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody. Subjects with Stable Schizophrenia
According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period.
Assessed by the investigator as having treatment-resistant schizophrenia; past or current diagnosis of neuroleptic malignant syndrome (NMS); anticipated need for antipsychotic regimen modifications during the study period;
History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation within the past 6 months, defined as affirmative responses ("yes") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening/baseline;
Subjects have used monoamine oxidase inhibitors (MAOI) within 28 days or any dietary supplements/traditional Chinese herbal products within 7 days prior to first dosing.
Glycated hemoglobin (HbA1c) ≥7% at screening/baseline.
Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate \<50 beats per minute (bpm) at screening/baseline; or QTc \>450 ms (male) / QTc \>460 ms (female) based on Fridericia's formula-corrected measurements at screening/baseline.
Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
Subjects with a history of orthostatic hypotension or syncope.
