A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLeal Therapeutics, Inc
About this trial
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.
Eligibility criteria
Qualifiers
BMI > 17.5 and < 38.0 kg/m2 and a total body weight > 50.0 kg (110 lbs)
Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)
Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study
PANSS total score ≥ 80 at the time of screening for the study
Disqualifiers
Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination
History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine
Current DSM-5-TR diagnosis other than schizophrenia
Pregnant or lactating female
Trial design
Treatments tested in this trial
- LTX-001 once daily
- Placebo
- LTX-001 twice daily
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov