NTX-253 for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Doug Feltner, MD
Principal Investigator
Neurosterix
Are You a Good Fit for This Trial?
This trial is for adults aged 18-55, both healthy and those with stable schizophrenia. Participants must not be pregnant or breastfeeding, should either live a truly abstinent lifestyle or use birth control, and have a BMI within specified ranges (17.5 to 36.0 kg/m2). Those with schizophrenia must have a PANSS score less than 80.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single ascending dose of NTX-253 or placebo, including a food effect cohort and a CSF cohort in healthy volunteers
Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses of NTX-253 or placebo for 10 consecutive days, including cohorts with stable schizophrenic participants
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NTX-253
Trial Overview
The study tests the safety and how the body processes NTX-253 when taken orally by healthy adults and adults with stable schizophrenia. It compares NTX-253 against a placebo in different groups of participants over single and multiple doses.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Participants will be assigned to receive one of multiple ascending daily oral doses of placebo for 10 days
Participants will be assigned to receive one of multiple single ascending daily oral doses of placebo
Participants will be assigned to receive one of multiple ascending oral daily doses of NTX-253 for 10 days
Participants will receive the maximum tolerated single oral dose of NTX-253
Participants will be assigned to receive one of multiple single ascending daily oral doses of NTX-253
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurosterix
Lead Sponsor
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