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RecruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests NTX-253, a drug taken by mouth, in healthy adults and adults with stable schizophrenia. It looks at safety, side effects, and how the drug moves through the body after single and repeated doses.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 55 years old.
  • Not be pregnant or breastfeeding. Be unable to become pregnant, fully avoid sex, or agree to use accepted birth control.
  • For Parts 1a/b and Part 2 Cohort 7, have a body mass index (BMI) of 18 to 30. BMI compares weight with height.
  • For the food-effect group, be willing to eat one high-fat breakfast.
  • For the schizophrenia groups in Part 2, have stable schizophrenia.
  • A BMI range of 17.5 to 36 is also listed.
  • Have a score below 80 on the PANSS test, which measures schizophrenia symptoms, at screening.

Who can't join

  • For Parts 1a/b and the healthy groups in Part 2, have a past or current major medical or mental illness.
  • Have been diagnosed with or treated for cancer in the past 7 years.
  • Have a stomach or bowel condition that could affect how the body handles or absorbs the drug.
  • Have a medically important abnormal result on an ECG, a test of the heart's electrical activity.
  • For Part 2, have a main mental health diagnosis other than schizophrenia.
  • For people with schizophrenia, have a history of treatment not working well enough, or have used clozapine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

CA