NTX-253 for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called NTX-253, a potential drug for schizophrenia, to assess its safety, tolerability, and how the body processes it. The study includes different groups: some will receive NTX-253, while others will receive a placebo (a pill with no active drug) in varying doses. It seeks adults with stable schizophrenia whose symptoms are under control and who are not resistant to treatment. Those with stable schizophrenia may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, helping researchers understand its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that NTX-253 is likely to be safe for humans?
Research has shown that NTX-253 looks promising in early studies. Initial tests found it safe, as animals tolerated it well without major side effects. However, NTX-253 is just beginning its first human trials. This phase primarily assesses safety and tolerability in people. While the results are promising, human trials are necessary to confirm safety. Researchers will closely monitor for any side effects to determine how safe NTX-253 is for humans.12345
Why do researchers think this study treatment might be promising for schizophrenia?
Researchers are excited about NTX-253 for schizophrenia because it offers a novel approach compared to current treatments like antipsychotics, which primarily target dopamine receptors. NTX-253 potentially works through a different mechanism, which might provide benefits for patients who do not respond well to existing therapies. This new treatment could lead to better management of symptoms with fewer side effects, making it a promising option for those with schizophrenia.
What evidence suggests that NTX-253 might be an effective treatment for schizophrenia?
Research has shown that NTX-253 is a promising new treatment for schizophrenia. It targets a specific part of the brain to control symptoms like hallucinations and delusions. This method differs from traditional medications and might be safer and more effective. Early studies suggest that NTX-253 can help balance brain signals, potentially reducing these symptoms. Although more research is needed, NTX-253 could improve outcomes for people with schizophrenia, making it an exciting option. Participants in this trial will receive NTX-253 in various dosing regimens to further evaluate its effectiveness and safety.12456
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
Citations
Single and Multiple Ascending Doses of NTX-253 in ...
This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult ...
2.
addextherapeutics.com
addextherapeutics.com/en/investors/press-releases/addex-spin-out-neurosterix-has-started-phase-1-clinical-study-m4-pam-ntx-253-schizophrenia/Addex Spin-Out Neurosterix has started a Phase 1 Clinical ...
NTX-253 is a potent, selective, orally available PAM of M4 that fine-tunes muscarinic signaling with the potential to reduce psychosis symptoms ...
3.
psychiatrictimes.com
psychiatrictimes.com/view/neurosterix-announces-phase-1-study-of-ntx-253-for-schizophreniaNeurosterix Announces Phase 1 Study of NTX-253 for ...
NTX-253 enters phase 1 trials, exploring a novel approach to schizophrenia treatment with potential for improved safety and efficacy.
4.
clival.com
clival.com/news/addex-spin-out-neurosterix-begins-phase-1-trial-of-novel-schizophrenia-drug-ntx-253Addex Spin-Out Neurosterix Begins Phase 1 Trial of Novel ...
NTX-253 is a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor. Unlike traditional ...
NTX-253 for Schizophrenia
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 ...
Addex Spin-Out Neurosterix has started a Phase 1 Clinical ...
NTX-253 is a potent, selective, orally available PAM of M4 that fine-tunes muscarinic signaling with the potential to reduce psychosis symptoms ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.