SchizophreniaPhase 1NCT07734493
A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
A Phase 1 study testing LTX-001 once daily and LTX-001 twice daily in people with Schizophrenia, run by Leal Therapeutics, Inc at 10 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LTX-001 once daily and LTX-001 twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Aug 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period
- Sexually active adults must be willing to use an acceptable contraceptive method throughout the study
Who cannot join
- 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
- Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening
- Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening
- Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Study Director Medical Monitor contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
Michael Mahaffey, m.mahaffey@cenexel.com
Kimball Johnson, MD
- Recruiting
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720
Bruce Rankin, bruce.rankin@accelclinical.com
Bruce Rankin, MD
- Recruiting
CBH Health LLC., dba CenExel Gaithersburg MD
Gaithersburg, Maryland, 20877
Elia Acevedo-Diaz, 301-251-4702
Elia Acevedo-Diaz, MD
- Recruiting
Behavioral Clinical Research, Inc.
Hollywood, Florida, 33021
Leandro Rueda, lrueda@segaltrials.com
Olga Lapeyra, MD
- Recruiting
CenExel Hollywood FL
Hollywood, Florida, 33024
Edwin A Gomez, 954-990-7649
Edwin A Gomez, MD
- Recruiting
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204
Leslie Smith, Studies@pillarhc.com
Leslie Smith, MD
- Recruiting
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
Study Recruiter, (714)-891-0971
David Walling, PhD
- Recruiting
Hassman Research Institute, LLC
Marlton, New Jersey, 08053
Lisa Wilkins, 888-437-4104, L.Wilkins@CenExel.com
Elan Cohen, MD
- Recruiting
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Leandro Rueda, lrueda@segaltrials.com
Rishi Kakar, MD
- Recruiting
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Scott Bartley, studies@pillarhc.com
Scott Bartley, MD
About this study
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
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)
Read more
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.
Read the detailed description
After providing informed consent, eligible participants will be asked to visit the study site 3 times and stay overnight for 35 nights (up to 49 nights if up to 14 days of antipsychotic washout is applicable). Procedures will include:
- A review of medical history and medications
- Physical exams, including a neurologic (nervous system) assessment
- Electrocardiograms (a measure of the heart's electrical activity)
- Blood and urine collection
- Psychiatric assessments including the Mini International Neuropsychiatric Exam (MINI), the Brief Assessment of Cognition in Schizophrenia (BACS), and the Positive and Negative Syndrome Scale (PANSS)
- Overall assessment of status via the Clinical Global Impression Scale - Severity (CGI-S)
- Assessment of extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)
- Assessment of suicidality risk via the Columbia Suicidality Severity Rating Scale (C-SSRS)
- Quantitative electroencephalography (qEEG) assessments
- Ophthalmologic examinations
- Administration of the study drug (or placebo) by mouth
- Conditions
- Schizophrenia
- Being tested
- LTX-001 once daily, Placebo, LTX-001 twice daily
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-001 once dailyDrug
LTX-001 40 mg and 60 mg administered as oral suspension
PlaceboDrug
Oral suspension without LTX-001
LTX-001 twice dailyDrug
LTX-001 30 mg and 60 mg administered as oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| LTX-001 once daily | Experimental | LTX-001 Receives: Drug: LTX-001 once daily |
| LTX-001 twice daily | Experimental | LTX-001 Receives: Drug: LTX-001 twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability - Adverse Events
Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs).
Measured: Screening through Day 42
Safety and Tolerability - Clinical Laboratory Tests
Clinical laboratory tests (including serum chemistry, hematology, urinalysis)
Measured: Screening through Day 42
Safety and Tolerability - Electrocardiograms (ECG)
ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals
Measured: Screening through Day 42
Safety and Tolerability - Physical and Neurological Exams
Physical and neurological exams will be performed periodically to ensure participant safety.
Measured: Screening through Day 42
Safety and Tolerability - Suicidality
Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Screening through Day 42
Safety and Tolerability - Extrapyramidal Symptoms
Extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)
Measured: Screening through Day 42
Vital signs - blood pressure
Vital signs will be collected, including blood pressure (mm Hg)
Measured: Screening through Day 42
Vital Signs - heart rate
Vital signs will be collected, including heart rate (beats per minute)
Measured: Screening through Day 42
Vital Signs - respiratory rate
Vital signs will be collected, including respiratory rate (breaths per minute)
Measured: Screening through Day 42
Vital Signs - body temperature
Vital signs will be collected, including body temperature (°C or °F)
Measured: Screening through Day 42
Vital Signs - total body weight
Vital signs will be collected, including total body weight (kilograms)
Measured: Screening through Day 42
Vital Signs - height
Vital signs will be collected, including height (centimeters)
Measured: Screening through Day 42
Vital Signs - Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated using the values of total body weight and height, with the formula BMI = weight in kg/(height in cm)^2.
Measured: Screening through Day 42
Ocular evaluation - Best Corrected Visual Acuity (BCVA)
Ocular evaluations, including Best Corrected Visual Acuity (BCVA) will be performed
Measured: Screening through Day 42
Ocular evaluation - dilated Color Fundus Photography (CFP)
Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed
Measured: Screening through Day 42
Ocular evaluation - Fundus Autofluorescence (FAF)
Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed
Measured: Screening through Day 42
Ocular evaluation - dilated Optical Coherence Tomography (OCT)
Ocular evaluations, including dilated Optical Coherence Tomography (OCT) of the macula and optic nerve will be performed
Measured: Screening through Day 42
Ocular evaluation - slit lamp examination
Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed
Measured: Screening through Day 42
Secondary outcomes (2)
Pharmacokinetics of LTX-001 - Single Dose
Single-dose plasma PK parameters (Days 1 and 8) will be measured
Measured: Days 1 and 8
Pharmacokinetics of LTX-001 - Multiple Dose
Multiple-dose plasma PK parameters (Day 35) will be measured.
Measured: Days 8 and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start3 Aug 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leal Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734493
- Sponsor's protocol ID
- LTX-001-103
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07734493
- Acronym / sponsor ID
- LTX-001-103
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Leal Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After providing informed consent, eligible participants will be asked to visit the study site 3 times and stay overnight for 35 nights (up to 49 nights if up to 14 days of antipsychotic washout is applicable). Procedures will include:
- A review of medical history and medications
- Physical exams, including a neurologic (nervous system) assessment
- Electrocardiograms (a measure of the heart's electrical activity)
- Blood and urine collection
- Psychiatric assessments including the Mini International Neuropsychiatric Exam (MINI), the Brief Assessment of Cognition in Schizophrenia (BACS), and the Positive and Negative Syndrome Scale (PANSS)
- Overall assessment of status via the Clinical Global Impression Scale - Severity (CGI-S)
- Assessment of extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)
- Assessment of suicidality risk via the Columbia Suicidality Severity Rating Scale (C-SSRS)
- Quantitative electroencephalography (qEEG) assessments
- Ophthalmologic examinations
- Administration of the study drug (or placebo) by mouth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| LTX-001 once daily | Experimental | Drug: LTX-001 once dailyLTX-001 |
| LTX-001 twice daily | Experimental | Drug: LTX-001 twice dailyLTX-001 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period
Key exclusion criteria (7 listed)
- 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
- Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTX-001 once dailyLTX-001 40 mg and 60 mg administered as oral suspension | Drug | LTX-001 once daily |
| PlaceboOral suspension without LTX-001 | Drug | Placebo |
| LTX-001 twice dailyLTX-001 30 mg and 60 mg administered as oral suspension | Drug | LTX-001 twice daily |
Primary outcome
Safety and Tolerability - Adverse Events
Time frame: Screening through Day 42
Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs).
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening through Day 42
Clinical laboratory tests (including serum chemistry, hematology, urinalysis)
Safety and Tolerability - Electrocardiograms (ECG)
Time frame: Screening through Day 42
ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals
Safety and Tolerability - Physical and Neurological Exams
Time frame: Screening through Day 42
Physical and neurological exams will be performed periodically to ensure participant safety.
Safety and Tolerability - Suicidality
Time frame: Screening through Day 42
Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Safety and Tolerability - Extrapyramidal Symptoms
Time frame: Screening through Day 42
Extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)
Vital signs - blood pressure
Time frame: Screening through Day 42
Vital signs will be collected, including blood pressure (mm Hg)
Vital Signs - heart rate
Time frame: Screening through Day 42
Vital signs will be collected, including heart rate (beats per minute)
Vital Signs - respiratory rate
Time frame: Screening through Day 42
Vital signs will be collected, including respiratory rate (breaths per minute)
Vital Signs - body temperature
Time frame: Screening through Day 42
Vital signs will be collected, including body temperature (°C or °F)
Vital Signs - total body weight
Time frame: Screening through Day 42
Vital signs will be collected, including total body weight (kilograms)
Vital Signs - height
Time frame: Screening through Day 42
Vital signs will be collected, including height (centimeters)
Vital Signs - Body Mass Index (BMI)
Time frame: Screening through Day 42
Body Mass Index (BMI) will be calculated using the values of total body weight and height, with the formula BMI = weight in kg/(height in cm)^2.
Ocular evaluation - Best Corrected Visual Acuity (BCVA)
Time frame: Screening through Day 42
Ocular evaluations, including Best Corrected Visual Acuity (BCVA) will be performed
Ocular evaluation - dilated Color Fundus Photography (CFP)
Time frame: Screening through Day 42
Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed
Ocular evaluation - Fundus Autofluorescence (FAF)
Time frame: Screening through Day 42
Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed
Ocular evaluation - dilated Optical Coherence Tomography (OCT)
Time frame: Screening through Day 42
Ocular evaluations, including dilated Optical Coherence Tomography (OCT) of the macula and optic nerve will be performed
Ocular evaluation - slit lamp examination
Time frame: Screening through Day 42
Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed
2 secondary outcomes
Pharmacokinetics of LTX-001 - Single Dose
Time frame: Days 1 and 8
Pharmacokinetics of LTX-001 - Multiple Dose
Time frame: Days 8 and 35
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director Medical Monitor contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LTX-001 once daily and LTX-001 twice daily in people with Schizophrenia, run by Leal Therapeutics, Inc at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Medical Monitor (267-503-4800, clinical.trials@lealtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability - Adverse Events (time frame: Screening through Day 42). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.