Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07191483

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cognitive Impairment Associated With Schizophrenia (CIAS) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Woodland International Research Group, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has an established primary psychiatric diagnosis of schizophrenia
  • Clinically stable and in the residual (nonacute) phase of their illness for at least 8 weeks before screening in the judgement of the investigator
  • Diagnosis of schizophrenia for at least 1 year before screening
  • Must be in ongoing maintenance antipsychotic monotherapy on a stable medication treatment regimen for ≥ 2 months before screening, including concomitant psychotropic medications.
  • Male or female, aged ≥18 and ≤55 years
  • Has a body mass index (BMI) between 18 and 40 kg/m2 Inclusive
  • Must exhibit capability to comply with all protocol procedures in the judgement of the investigator
  • Signed and dated written informed consent before screening in accordance with Good Clinical Practice.

Exclusion criteria

  • Currently being treated with more than 1 antipsychotic at the time of screening,
  • A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening
  • Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol)
  • Evidence of unstable medical condition

Treatment and study plan

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

Primary outcomes

  1. To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)

    Time frame: 28 days

    Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score

Secondary outcomes

  1. Cmax

    Time frame: 28 days

    Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28

  2. AUCtau

    Time frame: 28 Days

    Area under the concentration-time curve from time 0 to tau (end of dosing interval) (AUCtau) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28

  3. Tmax

    Time frame: 28 Days

    Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28

  4. Ctrough

    Time frame: 28 Days

    Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28

  5. Terminal half-life (t1/2)

    Time frame: 28 Days

    Terminal half-life (t1/2) after the last dose on Day 28 for KYN-5356 and relevant KYN-5356 metabolites

Sponsors and collaborators

Lead sponsor

Kynexis B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.