Single and multiple oral doses of NTX-253 in healthy adults and adults 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
This trial will test single and repeated oral doses of an experimental medicine called NTX-253 in healthy adults and adults with stable schizophrenia to see how safe it is and how the body handles the drug.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Neurosterix Industry-sponsored |
| Locations | 1 site (Los Alamitos, California) |
| Trial ID | NCT07344948 on ClinicalTrials.gov |
What this trial studies
This is an early-phase, placebo-controlled SAD (single ascending dose) and MAD (multiple ascending dose) trial that enrolls healthy volunteers and a limited number of adults with stable schizophrenia. Part 1 includes single ascending doses with a food-effect cohort and a cerebrospinal fluid (CSF) cohort in healthy volunteers, and Part 2 gives escalating doses daily for 10 days including cohorts of stable schizophrenia participants. Participants will receive either oral NTX-253 or placebo and will be monitored for safety, tolerability, and pharmacokinetics. Some schizophrenia cohorts will have antipsychotic medication withdrawn for up to eight days prior to dosing to evaluate tolerability in that population.
Who should consider this trial
Good fit: Ideal candidates are adults 18–55 who are either healthy volunteers meeting BMI and safety criteria or adults with stable schizophrenia (PANSS total <80) who meet the study's BMI and contraceptive requirements and can comply with clinic visits.
Not a fit: People with unstable or severe psychiatric illness, significant medical comorbidities, recent cancer treatment, abnormal ECGs, active gastrointestinal conditions affecting absorption, or who are pregnant or lactating are unlikely to be eligible or to benefit from this early safety-focused trial.
Why it matters
Potential benefit: If NTX-253 is safe and shows favorable drug levels, it could move to later trials and eventually become a new oral treatment option for schizophrenia.
How similar studies have performed: The SAD/MAD safety and pharmacokinetic design is a standard first step used successfully for many psychiatric drugs, but NTX-253 itself is a novel investigational compound with no established clinical efficacy yet.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Alamitos, California
- Collaborative Neuroscience Research, LLC - CenExel — Los Alamitos, California, United States (Recruiting)
Study contacts
- Study coordinator: Doug Feltner, Chief Medical Officer, MD
- Email: doug.feltner@neurosterix.com
- Phone: +41 22 884 15 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.