Recruiting
Early Phase 1

NTX-253

Sponsor:

Neurosterix

Code:

NCT07344948

Conditions

Healthy Participants

Schizophrenia Diagnosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

NTX-253

Placebo

Study Details

Brief 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.

Conditions

Healthy Participants

Schizophrenia Diagnosis

Study ID

NCT07344948

Start date

Oct 3, 2025

Status verified date

Jan, 2026

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

73 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTX-253 Part 1a

Participants will be assigned to receive one of multiple single ascending daily oral doses of NTX-253

experimental: Placebo Part 1a

Participants will be assigned to receive one of multiple single ascending daily oral doses of placebo

experimental: NTX-253 Part 1b

Participants will receive the maximum tolerated single oral dose of NTX-253

experimental: NTX-253 Part 2

Participants will be assigned to receive one of multiple ascending oral daily doses of NTX-253 for 10 days

experimental: Placebo Part 2

Participants will be assigned to receive one of multiple ascending daily oral doses of placebo for 10 days

Interventions

NTX-253

Oral Capsule

Placebo

Oral capsule

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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Doug Feltner, Chief Medical Officer, MD

+41 22 884 15 55doug.feltner@neurosterix.com

Lisa Corey

+41 22 884 15 55lisa.corey@neurosterix.com

Locations

Collaborative Neuroscience Research, LLC - CenExel

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Recruitment

866-787-4257alamitors.info@CenExel.com

More Information

Sponsor

Neurosterix

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • Phase 1
  • Healthy volunteer
  • Schizophrenia
  • Pharmacokinetics
  • Single ascending dose
  • Multiple ascending dose
  • Food effect
  • Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurosterix on 2026-01-15.