Early Phase 1 Schizophrenia Trial, Recruiting NCT07344948 Sponsor: Neurosterix Condition: Schizophrenia
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Early Phase 1 Schizophrenia Trial, Recruiting

NCT07344948
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men, or women who are not pregnant or breastfeeding, aged 18 to 55, who either cannot become pregnant, live a completely abstinent lifestyle, or agree to use an approved form of contraception
  • For certain parts of the trial (Part 1a/b and Part 2 Cohort 7): People whose body mass index (BMI — a measure of weight relative to height) falls between 18.0 and 30.0
  • For the food effect portion of the trial: People who are willing to eat a single high-fat breakfast as part of testing
  • For Part 2 only (schizophrenia group): People who have a stable diagnosis of schizophrenia
  • For Part 2 schizophrenia participants: People whose BMI falls between 17.5 and 36.0
  • For Part 2 schizophrenia participants: People whose symptom score on a standard psychiatric scale (called the PANSS) is below 80 at the initial screening appointment (confirm with trial site)

Who may not be able to join:

  • For healthy participants in Part 1 and Part 2: People who have a history of, or currently have, a significant physical or mental health condition
  • People who have been diagnosed with or treated for cancer in the past 7 years
  • People with ongoing or long-term digestive conditions that could affect how the body processes medication
  • People with a significant abnormality found on a heart tracing test (ECG)
  • For Part 2: People who have a primary psychiatric diagnosis other than schizophrenia, as defined by standard diagnostic guidelines (DSM-5TR)
  • People with schizophrenia whose condition has not responded to antipsychotic medications in the past, or who have previously used a medication called clozapine

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Doug Feltner, MD, Neurosterix

Phone: +41 22 884 15 55

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Neurosterix
Registry
ClinicalTrials.gov
Start date
3 October 2025
Est. completion
1 May 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of reported Adverse Events; Number of Adverse Events of Special Interest (AESI); Number of dose limiting treatment emergent adverse events (TEAE); Vital Signs: Change in blood pressure; Vital Signs: Change in temperature; Vital Signs: Change in respiratory rate; Vital Signs: Change in heart rate; Change in physical examination; Clinical Laboratory Tests

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov