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

Healthy Participants Schizophrenia Diagnosis

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

Inclusion Criteria6

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

Exclusion Criteria6

(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.