Healthy ParticipantsEarly Phase 1NCT07344948
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
A Early Phase 1 study testing NTX-253 in people with Healthy Participants and Schizophrenia Diagnosis, run by Neurosterix at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Schizophrenia Diagnosis
- What is being tested?
- NTX-253
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to May 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Collaborative Neuroscience Research, LLC - CenExel
Los Alamitos, California, 90720
Recruitment, 866-787-4257, alamitors.info@CenExel.com
About this study
Official title: 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 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.
Read the detailed 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. NTX-253 is an investigational drug being developed for the treatment of schizophrenia. The study will consist of a single ascending dose (SAD - Part 1a) phase which will include a food effect cohort, and a cerebrospinal fluid (CSF - Part 1b) cohort in healthy volunteers. Participants will receive a single dose of either oral NTX-253 or placebo. The multiple ascending dose (MAD - Part 2) phase will follow. In Part 2, participants will be dosed for 10 consecutive days with either NTX-253 or placebo. Each phase will include sequential escalating doses in healthy volunteers. Two cohorts in the MAD phase will include stable schizophrenic adult participants who have had antipsychotic medication withdrawn for up to 8 days prior to dosing with NTX-253.
- Conditions
- Healthy Participants, Schizophrenia Diagnosis
- Being tested
- NTX-253, Placebo
- Keywords
- Phase 1, Healthy volunteer, Schizophrenia, Pharmacokinetics, Single ascending dose, Multiple ascending dose, Food effect, Safety
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-253Drug
Oral Capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| NTX-253 Part 1a | Experimental | Participants will be assigned to receive one of multiple single ascending daily oral doses of NTX-253 Receives: Drug: NTX-253 |
| Placebo Part 1a | Experimental | Participants will be assigned to receive one of multiple single ascending daily oral doses of placebo Receives: Drug: Placebo |
| NTX-253 Part 1b | Experimental | Participants will receive the maximum tolerated single oral dose of NTX-253 Receives: Drug: NTX-253 |
| NTX-253 Part 2 | Experimental | Participants will be assigned to receive one of multiple ascending oral daily doses of NTX-253 for 10 days Receives: Drug: NTX-253 |
| Placebo Part 2 | Experimental | Participants will be assigned to receive one of multiple ascending daily oral doses of placebo for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reported Adverse Events
Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events.
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Number of Adverse Events of Special Interest (AESI)
Safety and tolerability will be assessed by the incidence and severity of AESIs.
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Number of dose limiting treatment emergent adverse events (TEAE)
Safety and tolerability will be assessed by the incidence and severity of serious or dose limiting TEAEs.
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Vital Signs: Change in blood pressure
Blood pressure measurements
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Vital Signs: Change in temperature
Oral temperature measurement
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Vital Signs: Change in respiratory rate
Respiratory rate (number of breaths per minute) measurements
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Vital Signs: Change in heart rate
Pulse measurements.
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Change in physical examination
Investigator will perform complete physical exam and document any clinically significant conditions.
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Clinical Laboratory Tests
Hematology, serum chemistry, urinalysis, and coagulation tests.
Measured: From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Secondary outcomes (9)
Maximum observed plasma concentration (Cmax) [Pharmacokinetics]
Samples will be collected periodically until:
- 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose.
- 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.
Measured: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.
Time of Cmax (tmax) [Pharmacokinetics]
Samples will be collected periodically until:
- 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose.
- 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.
Measured: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.
Apparent terminal half-life (t1/2)
Samples will be collected periodically until:
- 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose.
- 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.
Measured: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.
Amount of unchanged drug excreted in urine (Ae) [urinary excretion)
Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.
Measured: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.
Percent of dose excreted as unchanged drug in urine (Ae%) [urinary excretion]
Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.
Measured: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.
Renal clearance (Clr) [urinary excretion]
Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.
Measured: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.
Maximum observed CSF concentration (Cmax, CSF) [Pharmacokinetics]
CSF samples will be collected at periodic intervals until 12 hours after a single dose in a single dose CSF cohort.
Measured: From baseline until 12 hours after a single dose.
Time corresponding to Cmax (Tmax, CSF) [Pharmacokinetics]
CSF samples will be collected at periodic intervals until 12 hours after a single dose in a single dose CSF cohort.
Measured: From baseline until 12 hours after a single dose.
QT/QTc potential interval prolongation and plasma concentration
Electrocardiograms (ECGs) will be collected to assess the potential for QT/QTc interval prolongation and ΔQTc as measured by:
- Change from baseline in cardiac measurements
Measured: From baseline until 72 hours post-dose in the single dose cohorts, then from baseline until Day 13 in the multiple dose cohorts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start3 Oct 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Crossover design for fasted/fed cohort
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurosterix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doug Feltner, MD, Study director, Neurosterix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344948
- Sponsor's protocol ID
- NTX-0253-101
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07344948
- Acronym / sponsor ID
- NTX-0253-101
- Conditions
- Healthy Participants, Schizophrenia Diagnosis
- Keywords
- Phase 1, Healthy volunteer, Schizophrenia, Pharmacokinetics, Single ascending dose, Multiple ascending dose, Food effect, Safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- NeurosterixIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. NTX-253 is an investigational drug being developed for the treatment of schizophrenia. The study will consist of a single ascending dose (SAD - Part 1a) phase which will include a food effect cohort, and a cerebrospinal fluid (CSF - Part 1b) cohort in healthy volunteers. Participants will receive a single dose of either oral NTX-253 or placebo. The multiple ascending dose (MAD - Part 2) phase will follow. In Part 2, participants will be dosed for 10 consecutive days with either NTX-253 or placebo. Each phase will include sequential escalating doses in healthy volunteers. Two cohorts in the MAD phase will include stable schizophrenic adult participants who have had antipsychotic medication withdrawn for up to 8 days prior to dosing with NTX-253.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Crossover design for fasted/fed cohort
| Arm | Type | Receives |
|---|---|---|
| NTX-253 Part 1a | Experimental | Drug: NTX-253Participants will be assigned to receive one of multiple single ascending daily oral doses of NTX-253 |
| Placebo Part 1a | Experimental | Drug: PlaceboParticipants will be assigned to receive one of multiple single ascending daily oral doses of placebo |
| NTX-253 Part 1b | Experimental | Drug: NTX-253Participants will receive the maximum tolerated single oral dose of NTX-253 |
| NTX-253 Part 2 | Experimental | Drug: NTX-253Participants will be assigned to receive one of multiple ascending oral daily doses of NTX-253 for 10 days |
| Placebo Part 2 | Experimental | Drug: PlaceboParticipants will be assigned to receive one of multiple ascending daily oral doses of placebo for 10 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-253Oral Capsule | Drug | NTX-253 Part 1a, NTX-253 Part 1b, NTX-253 Part 2 |
| PlaceboOral capsule | Drug | Placebo Part 1a, Placebo Part 2 |
Primary outcome
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.
9 secondary outcomes
Maximum observed plasma concentration (Cmax) [Pharmacokinetics]
Time frame: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.
Time of Cmax (tmax) [Pharmacokinetics]
Time frame: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.
Apparent terminal half-life (t1/2)
Time frame: From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.
Amount of unchanged drug excreted in urine (Ae) [urinary excretion)
Time frame: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.
Percent of dose excreted as unchanged drug in urine (Ae%) [urinary excretion]
Time frame: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.
Renal clearance (Clr) [urinary excretion]
Time frame: From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.
Maximum observed CSF concentration (Cmax, CSF) [Pharmacokinetics]
Time frame: From baseline until 12 hours after a single dose.
Time corresponding to Cmax (Tmax, CSF) [Pharmacokinetics]
Time frame: From baseline until 12 hours after a single dose.
QT/QTc potential interval prolongation and plasma concentration
Time frame: From baseline until 72 hours post-dose in the single dose cohorts, then from baseline until Day 13 in the multiple dose cohorts.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doug Feltner, MD study director
Neurosterix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NTX-253 in people with Healthy Participants and Schizophrenia Diagnosis, run by Neurosterix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doug Feltner, Chief Medical Officer, MD (+41 22 884 15 55, doug.feltner@neurosterix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.