Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-03

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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Two cohorts in the MAD phase will include stable schizophrenic adult participants who have had antipsychotic medication withdrawn for up to 8 days prior to dosing with NTX-253.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

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Healthy Participants Schizophrenia Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Crossover design for fasted/fed cohort

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NTX-253 Part 1a

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

Group Type EXPERIMENTAL

NTX-253

Intervention Type DRUG

Oral Capsule

Placebo Part 1a

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Oral capsule

NTX-253 Part 1b

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

Group Type EXPERIMENTAL

NTX-253

Intervention Type DRUG

Oral Capsule

NTX-253 Part 2

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

Group Type EXPERIMENTAL

NTX-253

Intervention Type DRUG

Oral Capsule

Placebo Part 2

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Oral capsule

Interventions

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NTX-253

Oral Capsule

Intervention Type DRUG

Placebo

Oral capsule

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes