NCT07344948 · Neurosterix
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
What this study is about
This study will assess the safety, tolerability, and how the drug moves through the body of NTX-253 following taken by mouth administration in both healthy adult participants as well as adult participants with stable schizophrenia.
View original scientific description
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.
Interventions
DRUG
NTX-253
Oral Capsule
DRUG
Placebo
Oral capsule
Primary outcome measures
Number of reported Adverse Events
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events.
Number of Adverse Events of Special Interest (AESI)
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Safety and tolerability will be assessed by the incidence and severity of AESIs.
Number of dose limiting treatment emergent adverse events (TEAE)
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Safety and tolerability will be assessed by the incidence and severity of serious or dose limiting TEAEs.
Vital Signs: Change in blood pressure
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Blood pressure measurements
Vital Signs: Change in temperature
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Oral temperature measurement
Vital Signs: Change in respiratory rate
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Respiratory rate (number of breaths per minute) measurements
Vital Signs: Change in heart rate
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Pulse measurements.
Change in physical examination
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Investigator will perform complete physical exam and document any clinically significant conditions.
Clinical Laboratory Tests
Time frame: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Hematology, serum chemistry, urinalysis, and coagulation tests.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Alamitos, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations