KYN-5356 for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, KYN-5356, to evaluate its efficacy and safety in treating schizophrenia. Participants will receive a low, medium, or high dose of the medication, or a placebo, for 28 days. The goal is to understand how different doses affect symptoms and brain function in individuals with schizophrenia. Eligible participants must have been diagnosed with schizophrenia for at least a year, be stable in their condition, and have been taking only one antipsychotic medication for at least two months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in schizophrenia treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you stay on your current antipsychotic medication if it's a single, stable treatment you've been on for at least 2 months. You cannot be on more than one antipsychotic medication.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that KYN-5356 has been safe in earlier human studies. In a previous trial, healthy participants handled the treatment well, with no major safety issues reported. The treatment is a small molecule targeting an enzyme called KAT-II, which plays a role in brain function.
Participants in the initial studies did not experience significant negative side effects, suggesting that KYN-5356 is generally well-tolerated. However, as with any treatment, individual reactions may vary. Participants should discuss any concerns with the trial team.12345Why are researchers excited about this trial's treatments?
Most treatments for schizophrenia, like antipsychotics, work by blocking dopamine receptors. However, KYN-5356 is unique because it targets a different pathway in the brain, potentially offering relief with fewer side effects. Researchers are excited about KYN-5356 because it could provide a new option for patients who don't respond well to existing medications. By offering different doses—low, medium, and high—this treatment could be tailored to individual patient needs, which is a big step forward in personalized medicine for schizophrenia.
What evidence suggests that this trial's treatments could be effective for schizophrenia?
Research shows that KYN-5356 is designed to improve thinking and memory in people with schizophrenia. In earlier studies, patients demonstrated that KYN-5356 was safe and worked well in the body, as it was absorbed and processed effectively. As the first of its kind tested in humans, KYN-5356 targets specific brain functions linked to thinking problems in schizophrenia. Although human studies have provided limited information, early results suggest that KYN-5356 might help manage cognitive symptoms related to the condition. Participants in this trial will receive either a high, medium, or low dose of KYN-5356, or a placebo, to further evaluate its effectiveness and safety.12367
Are You a Good Fit for This Trial?
Adults with cognitive impairment due to schizophrenia may join this trial. Participants will stay in a clinic for 32 days and take the study drug or placebo for 28 days. They must be able to undergo various assessments, including safety checks and possibly brain function tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KYN-5356 or placebo for 28 days with efficacy, safety, PK, and PD assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KYN-5356 High Dose
- KYN-5356 low dose
- KYN-5356 Medium Dose
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kynexis B.V.
Lead Sponsor