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Study identifier: NCT07191483 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Cognitive Impairment Associated With Schizophrenia (CIAS)  ·  Sponsor: Kynexis B.V.

PhasePhase 2
Planned participants150
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (15)

Woodland International Research GroupLittle Rock, Arkansas, United StatesRecruiting
Synapse Clinical TrialsCerritos, California, United StatesRecruiting
Synergy Research CenterLemon Grove, California, United StatesRecruiting
Cenexel CNSLos Alamitos, California, United StatesRecruiting
NeuroBehavioral Hospitals of the Palm Beaches - SouthBoynton Beach, Florida, United StatesRecruiting
Cenexel RCAHollywood, Florida, United StatesRecruiting
Segal TrialsMiami Lakes, Florida, United StatesTerminated
Cenexel ACMRAtlanta, Georgia, United StatesRecruiting
Cenexel iResearch AtlantaDecatur, Georgia, United StatesRecruiting
Uptown Research InstituteChicago, Illinois, United StatesRecruiting
Cenexel CBHGaithersburg, Maryland, United StatesRecruiting
Arch Clinical TrialsSt Louis, Missouri, United StatesRecruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07191483