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Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia

RecruitingEARLY Phase 1Ages 18 Years - 55 YearsAllNeurosterix
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In plain words

What the trial is, and whether it could suit you

This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.

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📋 Eligibility rules (as published)
Primary Inclusion Criteria: * Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control * Part 1 a/b, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg/m2 * Participants in the food effect cohort must be willing to eat a single high fat breakfast * (Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only) * Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg/m2 * Positive and Negative Syndrome Scale (PANSS) total score \<80 at screening Primary Exclusion Criteria: * (Part 1a/b, Part 2 Healthy): History of or current clinically significant medical or mental illness * Cancer diagnosis/treatment in the past 7 years * Acute or chronic gastrointestinal conditions that would interfere with drug tolerance or absorption * Any clinically significant, abnormal 12 lead ECG * Part 2: Any primary DSM-5TR disorder other than schizophrenia * Participants with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history; history of clozapine use.
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What it tests

  • NTX-253
  • Placebo
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Where

1 site
Collaborative Neuroscience Research, LLC - CenExel
Los Alamitos, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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