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Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
RecruitingEarly phase 1Healthy volunteers welcome
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
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- NTX-253 (drug)
- Placebo (drug)
Sponsor: Neurosterix · Participants: 73 · Started: Oct 3, 2025
Contact the study team
- Doug Feltner, Chief Medical Officer, MD · Phone: +41 22 884 15 55
- Lisa Corey · Phone: +41 22 884 15 55
Official record on ClinicalTrials.gov — NCT07344948
Locations in the U.S.
| California | Collaborative Neuroscience Research, LLC - CenExel, Los Alamitos |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.