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

Conditions

• Healthy Participants
• Schizophrenia Diagnosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• NTX-253 — DRUG
  Oral Capsule
• Placebo — DRUG
  Oral capsule

Study Details

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.

Key Dates

Start date

Oct 3, 2025

Status verified

Jan 2026

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

73 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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). ]

Central Contacts

• Doug Feltner, Chief Medical Officer, MD
  +41 22 884 15 55
  [email protected]
• Lisa Corey
  +41 22 884 15 55
  [email protected]

Locations (1)

Find similar trials in Los Alamitos, CA

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