A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
Recruiting
Phase 1
Interventional Study
Schizophrenia
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Leal Therapeutics, Inc · Industry
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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 affec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 th…
Contacts
Study Director Medical Monitor
CONTACT