RecruitingPhase 2NCT07191483

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


Sponsor

Kynexis B.V.

Enrollment

150 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called KYN-5356 to see whether it can improve thinking and memory problems (cognitive impairment) in adults with schizophrenia whose symptoms are otherwise stable. **You may be eligible if...** - You are between 18 and 55 years old - You have a confirmed diagnosis of schizophrenia for at least 1 year - Your schizophrenia has been stable (not in an acute crisis) for at least 8 weeks - You are taking a single antipsychotic medication on a stable dose for at least 2 months - Your BMI is between 18 and 40 **You may NOT be eligible if...** - You are currently taking more than one antipsychotic medication - You have moderate to severe substance use disorder (other than nicotine or caffeine) - You have unstable medical conditions - You score 2 or higher on any movement-side-effect rating scale item Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKYN-5356 low dose

oral tablet

OTHERPlacebo

Oral tablet

DRUGKYN-5356 Medium Dose

oral tablet

DRUGKYN-5356 High Dose

oral tablet


Locations(13)

Woodland International Research Group

Little Rock, Arkansas, United States

Synergy Research Center

Lemon Grove, California, United States

Cenexel CNS

Los Alamitos, California, United States

Cenexel RCA

Hollywood, Florida, United States

Segal Trials

Miami Lakes, Florida, United States

Cenexel ACMR

Atlanta, Georgia, United States

Cenexel iResearch Atlanta

Decatur, Georgia, United States

Uptown Research Institute

Chicago, Illinois, United States

Cenexel CBH

Gaithersburg, Maryland, United States

Arch Clinical Trials

St Louis, Missouri, United States

Cenexel HRI

Marlton, New Jersey, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

Community Clinical Research

Austin, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07191483