NCT07191483

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With Schizophrenia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Kynexis B.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Impairment Associated With Schizophrenia (CIAS)

Interventions

Type	Name	Description
DRUG	KYN-5356 low dose	oral tablet
OTHER	Placebo	Oral tablet
DRUG	KYN-5356 Medium Dose	oral tablet
DRUG	KYN-5356 High Dose	oral tablet

Timeline

• Start date: 2025-08-27
• Primary completion: 2025-10-01
• Completion: 2026-12-01
• First posted: 2025-09-24
• Last updated: 2025-09-25

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study