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

NCT07344948 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-01-15

No results posted yet for this study

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

Interventions

DRUG

NTX-253

Oral Capsule

DRUG

Placebo

Oral capsule

Sponsors & Collaborators

  • Neurosterix

    lead INDUSTRY

Principal Investigators

  • Doug Feltner, MD · Neurosterix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344948 on ClinicalTrials.gov