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

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.

NCT Number	NCT07191483
Lead Sponsor	Kynexis B.V.
Conditions	Cognitive Impairment Associated With Schizophrenia (CIAS)
Enrollment	150 participants
Start Date	2025-08-27
Primary Completion	2026-10 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-23