RecruitingEarly Phase 1NCT07344948

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

A First in Human, Phase 1/1b Study of Single and Multiple Ascending Dosing Administration of NTX110253 in Healthy Participants and Participants With Stable Schizophrenia


Sponsor

Neurosterix

Enrollment

73 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called NTX-253 — first in healthy people to check safety and dosing, then in people with stable schizophrenia to assess its effects on symptoms. The goal is to understand how the drug behaves in the body and whether it is tolerated well. **You may be eligible if...** - You are 18–55 years old - You are generally in good health (or, for the schizophrenia portion, have stable schizophrenia) - You are not pregnant or breastfeeding and agree to use birth control if needed - If in the schizophrenia group, your symptom score (PANSS) is below 80 **You may NOT be eligible if...** - You have a significant medical illness or mental health condition (healthy participants only) - You have been diagnosed with or treated for cancer in the past 7 years - You have serious digestive problems that could affect how the drug is absorbed - You have a significant abnormality on your heart tracing (ECG) - You have a primary psychiatric diagnosis other than schizophrenia (schizophrenia group) or have treatment-resistant schizophrenia or a history of clozapine use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNTX-253

Oral Capsule

DRUGPlacebo

Oral capsule


Locations(1)

Collaborative Neuroscience Research, LLC - CenExel

Los Alamitos, California, United States

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NCT07344948


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