Phase 2 Study of KYN-5356 for Adults Aged 18-55 with Cognitive Impairment in Schizophrenia Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Brain Function Effects

What this Trial Is About

Researchers are evaluating the efficacy, safety, and pharmacological effects of three different doses of KYN-5356 compared to a placebo in adults with cognitive impairment associated with schizophrenia. This Phase 2, randomized, double-blind, placebo-controlled study aims to investigate how these treatments affect cognitive function and brain activity. The study assesses pharmacokinetics and exploratory pharmacodynamics to understand how the drug behaves and impacts neurophysiological measures in the brain. Participants will be randomly assigned to one of four groups receiving either low, medium, or high doses of KYN-5356 or a placebo. Treatment involves taking oral tablets daily for 28 days while residing in the clinic. Participants are admitted three days before treatment begins and remain in the clinic for 32 days. Electrophysiological tests will be performed on a subset of participants to evaluate the drugs effect on brain function. During the study, participants will undergo frequent evaluations for efficacy, safety, and drug levels in the body. Safety assessments continue until discharge on Day 29, followed by a follow-up visit on Day 42. Researchers will measure cognitive function changes and monitor pharmacokinetic parameters such as maximum concentration and half-life. The total participation period includes the 32-day residential stay plus the follow-up visit, allowing close monitoring throughout.

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