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90 Participants NeededMy employer runs this trial

LTX-001 for Schizophrenia

Recruiting at 9 trial locations
CT
SD
Overseen ByStudy Director Medical Monitor
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Leal Therapeutics, Inc
Must not be taking: Psychotropics, Clozapine
Disqualifiers: Organ dysfunction, Treatment resistance, Substance use, others

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with schizophrenia who are currently experiencing a recent worsening of their symptoms. Participants must be able to stay in a research unit for about five weeks and return for a follow-up visit.

Inclusion Criteria

I have had a recent flare-up of my symptoms within the last 2 months.
BMI > 17.5 and < 38.0 kg/m2 and a total body weight > 50.0 kg (110 lbs)
PANSS total score ≥ 80 at the time of screening
See 3 more

Exclusion Criteria

Substance use disorder within 1 year prior to screening or recreational drug use within 3 months prior to screening
I have organ problems or abnormal findings on my physical exam.
Moderate to severe alcohol use disorder per DSM-5-TR within past year or excessive alcohol use within 12 months prior to screening
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive LTX-001 or placebo, with various assessments including pharmacokinetics and pharmacodynamics over a 5-week inpatient stay

5 weeks
35 nights inpatient stay

Follow-up

Participants return for a follow-up visit to monitor safety and effectiveness after treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing the safety and effects of LTX-001, given either once or twice daily, compared to a placebo. Researchers will look at how the drug affects symptoms, its levels in the body over time, and changes in blood markers.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: LTX-001 twice dailyExperimental Treatment1 Intervention
Group II: LTX-001 once dailyExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Leal Therapeutics, Inc

Lead Sponsor

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