A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
Public ClinicalTrials.gov record NCT07734493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b, Multicenter, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Early Signs of Efficacy of Orally Administered LTX-001 As Monotherapy in Adult Participants With Acute Exacerbation of Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07734493
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 3, 2026 (Actual)
- Primary completion
- Mar 2027 (Estimated)
- Completion
- Mar 2027 (Estimated)
- Last update posted
- Sep 17, 2026
2026 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research, LLC | Little Rock | Arkansas | 72204 | Recruiting |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | Recruiting |
| University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit | DeLand | Florida | 32720 | Recruiting |
| Behavioral Clinical Research, Inc. | Hollywood | Florida | 33021 | Recruiting |
| CenExel Hollywood FL | Hollywood | Florida | 33024 | Recruiting |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | Recruiting |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | Recruiting |
| CBH Health LLC., dba CenExel Gaithersburg MD | Gaithersburg | Maryland | 20877 | Recruiting |
| Hassman Research Institute, LLC | Marlton | New Jersey | 08053 | Recruiting |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07734493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 17, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07734493 live on ClinicalTrials.gov.