The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are: * how does the amount of the study drug in the body change over time (pharmacokinetics) * how does the study drug affect the symptoms of schizophrenia * how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics) Researchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments. After successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety and Tolerability - Adverse Events
Timeframe: Screening through Day 42
Safety and Tolerability - Clinical Laboratory Tests
Timeframe: Screening through Day 42
Safety and Tolerability - Electrocardiograms (ECG)
Timeframe: Screening through Day 42
Safety and Tolerability - Physical and Neurological Exams
Timeframe: Screening through Day 42
Safety and Tolerability - Suicidality
Timeframe: Screening through Day 42
Safety and Tolerability - Extrapyramidal Symptoms
Timeframe: Screening through Day 42
Vital signs - blood pressure
Timeframe: Screening through Day 42
Clinical Trials Information Medical Monitor
Vital Signs - heart rate
Timeframe: Screening through Day 42
Vital Signs - respiratory rate
Timeframe: Screening through Day 42
Vital Signs - body temperature
Timeframe: Screening through Day 42
Vital Signs - total body weight
Timeframe: Screening through Day 42
Vital Signs - height
Timeframe: Screening through Day 42
Vital Signs - Body Mass Index (BMI)
Timeframe: Screening through Day 42
Ocular evaluation - Best Corrected Visual Acuity (BCVA)
Timeframe: Screening through Day 42
Ocular evaluation - dilated Color Fundus Photography (CFP)
Timeframe: Screening through Day 42
Ocular evaluation - Fundus Autofluorescence (FAF)
Timeframe: Screening through Day 42
Ocular evaluation - dilated Optical Coherence Tomography (OCT)
Timeframe: Screening through Day 42
Ocular evaluation - slit lamp examination
Timeframe: Screening through Day 42