Clinical Trials in the USA / NCT07344948
Recruiting
Early Phase 1
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
NCT07344948 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy ParticipantsSchizophrenia Diagnosis
Investigational drug(s) / intervention(s)
NTX-253Placebo
NTX-253: Oral Capsule
Placebo: Oral capsule
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.
Eligibility
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.
Primary outcome measure(s)
- Number of reported Adverse Events — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events. - Number of Adverse Events of Special Interest (AESI) — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Safety and tolerability will be assessed by the incidence and severity of AESIs. - Number of dose limiting treatment emergent adverse events (TEAE) — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Safety and tolerability will be assessed by the incidence and severity of serious or dose limiting TEAEs. - Vital Signs: Change in blood pressure — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Blood pressure measurements - Vital Signs: Change in temperature — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Oral temperature measurement - Vital Signs: Change in respiratory rate — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Respiratory rate (number of breaths per minute) measurements - Vital Signs: Change in heart rate — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Pulse measurements. - Change in physical examination — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Investigator will perform complete physical exam and document any clinically significant conditions. - Clinical Laboratory Tests — From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
Hematology, serum chemistry, urinalysis, and coagulation tests.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Collaborative Neuroscience Research, LLC - CenExel | Los Alamitos | California | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07344948 on ClinicalTrials.gov ↗ ← All trials in the USA