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

Neurosterix

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy Participants; Schizophrenia Diagnosis

Treatments: Drug: NTX-253; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07344948

NTX-0253-101

Details and patient eligibility

About

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.

Full description

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cohorts in the MAD phase will include stable schizophrenic adult participants who have had antipsychotic medication withdrawn for up to 8 days prior to dosing with NTX-253.

Enrollment: 73 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 5 patient groups

NTX-253 Part 1a

Experimental group

Description:

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

Treatment:

Drug: NTX-253

Placebo Part 1a

Experimental group

Description:

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

Treatment:

Drug: Placebo

NTX-253 Part 1b

Experimental group

Description:

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

Treatment:

Drug: NTX-253

NTX-253 Part 2

Experimental group

Description:

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

Treatment:

Drug: NTX-253

Placebo Part 2

Experimental group

Description:

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

Treatment:

Drug: Placebo