NCT07344948RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- Oct 2025
- Primary completion date
- May 2026
- Lead sponsor
- Neurosterix
- Diseases
- Schizophrenia
- NCT number
- NCT07344948
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 73
- From Oct 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Collaborative Neuroscience Research, LLC - CenExel Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.