A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
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
Interventions
KYN-5356 low dose
Placebo
KYN-5356 Medium Dose
KYN-5356 High Dose
Conditions
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