A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

Exclusion Criteria

• •1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
• •2. Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
• •3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
• •4. Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
• •5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
• •6. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
• •7. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS.
• •8. Clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results at screening that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
• •9. Subjects are receiving or have recently received (within 5 half-lives or 1 week, whichever is longer, before baseline \[Day -1\]) oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (e.g., lamotrigine, valproate); tricyclic antidepressants (e.g., imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate).
• •10. Subjects are receiving or have recently received (within 1 week before baseline \[Day -1\]) metformin.
• •11. Pregnant, lactating, or less than 3 months postpartum.
• •12. In the opinion of the investigator and/or Sponsor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator and/or Sponsor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
• •13. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
• •14. Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or has required clozapine within the last 12 months.
• •15. Subjects with prior exposure to KarXT.
• •16. Subjects who experienced any significant adverse effects due to trospium chloride.
• •17. Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent.
• •18. Significant risk of violent or destructive behavior.