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

Conditions

• Cognitive Impairment Associated With Schizophrenia (CIAS)

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• KYN-5356 low dose — DRUG
  oral tablet
• Placebo — OTHER
  Oral tablet
• KYN-5356 Medium Dose — DRUG
  oral tablet
• KYN-5356 High Dose — DRUG
  oral tablet

Study Details

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.

Key Dates

Start date

Aug 27, 2025

Status verified

Sep 2025

Primary completion

Oct 31, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: KYN-5356 low dose
  KYN-5356 low dose, oral tablet for 28 days
• Experimental: KYN-5356 medium dose
  KYN-5356 medium dose, oral tablet for 28 days
• Experimental: KYN-5356 high dose
  KYN-5356 high dose, oral tablet for 28 days
• Placebo Comparator: Placebo
  Placebo, oral tablet for 28 days

Primary Outcome Measure

To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS) [ Time Frame: 28 days ]

Locations (13)

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