Evaluating Safety and Effects of Oral LTX-001 in Adults with Recent Worsening of Schizophrenia Symptoms

What this Trial Is About

Researchers are studying the investigational drug LTX-001 to determine its safety and tolerability in adults diagnosed with schizophrenia who are experiencing a recent worsening of symptoms, known as an acute exacerbation. This early-phase trial also examines how the drug behaves in the body over time, how it affects schizophrenia symptoms, and changes in certain blood markers after taking LTX-001. Participants will be randomly assigned to receive different doses of LTX-001 or a placebo to compare effects. Eligible participants will stay overnight in a research unit for about five weeks, or up to 49 nights if they require up to 14 days to stop current antipsychotic medications before starting the study drug. They will take LTX-001 or placebo orally once or twice daily depending on the assigned dose. During the trial, participants will visit the study site three times for assessments including medical history review, physical and neurological exams, heart monitoring, blood and urine tests, psychiatric evaluations, and eye exams. Throughout the study and until Day 42, researchers will monitor participants for safety by tracking adverse events, lab tests, vital signs, heart activity, neurological exams, and suicidality risk. They will also assess drug levels in the body on specific days. After the treatment period, participants return for a follow-up visit one week later. Assessments include symptom scales, cognitive tests, and detailed psychiatric and physical evaluations to understand the drugs effects and safety profile.

A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia