New schizophrenia pill enters human safety testing

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Healthy Subjects * Subjects sign informed consent voluntarily. * Male or female aged 18 to 45 years. * 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. Exclusion Criteria: 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.