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RecruitingPhase 2

A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With 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
Not 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

  • Time periods mentioned: 32 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period."
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 three doses of KYN-5356 against a placebo (a pill with no study drug) in adults with schizophrenia who have trouble with thinking and memory. It checks how well the drug works, its safety, and how it acts in the body during 28 days of treatment. Participants stay at the clinic for 32 days and return for a follow-up visit on Day 42.

This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 and placebo for 28 days. Participants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose. Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period. Participants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42. A subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.

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

Eligibility

Who can join

  • Are 18 to 55 years old.
  • Have schizophrenia as your main mental health diagnosis, diagnosed at least 1 year before screening.
  • Have had stable symptoms, with no acute flare-up, for at least 8 weeks before screening, as judged by the study doctor.
  • Take only one antipsychotic medicine to manage schizophrenia. Your medicine plan, including other mental health medicines, must be unchanged for at least 2 months before screening.
  • Have a body mass index (BMI), a measure based on height and weight, from 18 to 40.
  • Can follow all study steps, as judged by the study doctor.
  • Sign and date a written consent form before screening.

Who can't join

  • Take more than one antipsychotic medicine at screening.
  • Score 2 or higher on any item of the Modified Simpson-Angus Scale, a check for movement-related side effects, at screening.
  • Have a moderate or severe substance use disorder, including alcohol. Nicotine and caffeine use disorders do not count.
  • Have a medical condition that is not stable.

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

Official eligibility criteria

Inclusion Criteria: * Has an established primary psychiatric diagnosis of schizophrenia * Clinically stable and in the residual (nonacute) phase of their illness for at least 8 weeks before screening in the judgement of the investigator * Diagnosis of schizophrenia for at least 1 year before screening * Must be in ongoing maintenance antipsychotic monotherapy on a stable medication treatment regimen for ≥ 2 months before screening, including concomitant psychotropic medications. * Male or female, aged ≥18 and ≤55 years * Has a body mass index (BMI) between 18 and 40 kg/m2 Inclusive * Must exhibit capability to comply with all protocol procedures in the judgement of the investigator * Signed and dated written informed consent before screening in accordance with Good Clinical Practice. Exclusion Criteria: * Currently being treated with more than 1 antipsychotic at the time of screening, * A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening * Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol) * Evidence of unstable medical condition

Study sites (15)

AR

CA

FL

GA

IL

MD

MO

NJ

OH

TX