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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Collaborative Neuroscience Research, LLC - CenExel
RECRUITING
Los Alamitos
Contact Information
Primary
Doug Feltner, Chief Medical Officer, MD
doug.feltner@neurosterix.com
+41 22 884 15 55
Backup
Lisa Corey
lisa.corey@neurosterix.com
+41 22 884 15 55
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2026-05
Participants
Target number of participants: 73
Treatments
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
Related Therapeutic Areas
Schizophrenia
Sponsors
Leads: Neurosterix

This content was sourced from clinicaltrials.gov

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