Actively Recruiting
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
Led by Neurosterix · Updated on 2026-01-15
73
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agree to use medically acceptable forms of birth control
- Body mass index (BMI) within 18.0 to 30.0 kg/m2 for Part 1 a/b and Part 2 Cohort 7
- Participants in the food effect cohort must be willing to eat a single high fat breakfast
- Stable schizophrenia participants in Part 2 only
- Body mass index (BMI) within 17.5 to 36.0 kg/m2 for schizophrenia cohorts
- Positive and Negative Syndrome Scale (PANSS) total score less than 80 at screening for schizophrenia cohorts
You will not qualify if you...
- History of or current clinically significant medical or mental illness (Part 1a/b, Part 2 Healthy)
- Cancer diagnosis or treatment in the past 7 years
- Acute or chronic gastrointestinal conditions interfering with drug tolerance or absorption
- Any clinically significant, abnormal 12 lead ECG
- Any primary DSM-5TR disorder other than schizophrenia (Part 2)
- Participants with schizophrenia considered resistant or refractory to antipsychotic treatment by history
- History of clozapine use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Collaborative Neuroscience Research, LLC - CenExel
Los Alamitos, California, United States, 90720
Actively Recruiting
Research Team
D
Doug Feltner, Chief Medical Officer, MD
CONTACT
L
Lisa Corey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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