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

NCT07191483 · tracked via the Priya Life Science USA tracker

Sponsor

Kynexis B.V.

Phase

Phase 2

Started

2025-08-27

Last updated

2026-06-23

Condition(s) studied

Cognitive Impairment Associated With Schizophrenia (CIAS)

Investigational drug(s) / intervention(s)

KYN-5356 low dosePlaceboKYN-5356 Medium DoseKYN-5356 High Dose

KYN-5356 low dose: oral tablet

Placebo: Oral tablet

KYN-5356 Medium Dose: oral tablet

KYN-5356 High Dose: oral tablet

Study 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

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

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

Primary outcome measure(s)

To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS) — 28 days
Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score

Trial sites (15)

Facility	City	Region	Status
Woodland International Research Group	Little Rock	Arkansas	Recruiting
Synapse Clinical Trials	Cerritos	California	Recruiting
Synergy Research Center	Lemon Grove	California	Recruiting
Cenexel CNS	Los Alamitos	California	Recruiting
NeuroBehavioral Hospitals of the Palm Beaches - South	Boynton Beach	Florida	Recruiting
Cenexel RCA	Hollywood	Florida	Recruiting
Segal Trials	Miami Lakes	Florida	Terminated
Cenexel ACMR	Atlanta	Georgia	Recruiting
Cenexel iResearch Atlanta	Decatur	Georgia	Recruiting
Uptown Research Institute	Chicago	Illinois	Recruiting
Cenexel CBH	Gaithersburg	Maryland	Recruiting
Arch Clinical Trials	St Louis	Missouri	Recruiting
Cenexel HRI	Marlton	New Jersey	Recruiting
Neuro-Behavioral Clinical Research	North Canton	Ohio	Recruiting
Community Clinical Research	Austin	Texas	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07191483 on ClinicalTrials.gov ↗ ← All trials in the USA