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NCT07191483PHASE2Recruiting

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

Kynexis B.V.

Start Date

8/27/2025

Completion Date

12/1/2026

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 Criteria

Age Range: 18 years to 55 years

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

Interventions

DRUG

KYN-5356 low dose

OTHER

Placebo

DRUG

KYN-5356 Medium Dose

DRUG

KYN-5356 High Dose

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Conditions

Cognitive Impairment Associated With Schizophrenia (CIAS)

Locations

Woodland International Research Group

Little Rock, Arkansas 72211

United States

Synapse Clinical Trials

Cerritos, California 80703

United States

Synergy Research Center

Lemon Grove, California 92064

United States

Cenexel CNS

Los Alamitos, California 90720

United States

NeuroBehavioral Hospitals of the Palm Beaches - South

Boynton Beach, Florida 33426

United States

Cenexel RCA

Hollywood, Florida 33024

United States

Segal Trials

Miami Lakes, Florida 33016

United States

Cenexel ACMR

Atlanta, Georgia 30331

United States

Cenexel iResearch Atlanta

Decatur, Georgia 30030

United States

Uptown Research Institute

Chicago, Illinois 60640

United States

Cenexel CBH

Gaithersburg, Maryland 20877

United States

Arch Clinical Trials

St Louis, Missouri 63125

United States

Cenexel HRI

Marlton, New Jersey 08053

United States

Neuro-Behavioral Clinical Research

North Canton, Ohio 44720

United States

Community Clinical Research

Austin, Texas 78754

United States