Recruiting
Phase 2

KYN-5356

Sponsor:

Kynexis B.V.

Code:

NCT07191483

Conditions

Cognitive Impairment Associated With Schizophrenia (CIAS)

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

KYN-5356 low dose

Placebo

KYN-5356 Medium Dose

KYN-5356 High Dose

Study Details

Brief 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)

Study ID

NCT07191483

Start date

Aug 27, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

KYN-5356 low dose

oral tablet

Placebo

Oral tablet

KYN-5356 Medium Dose

oral tablet

KYN-5356 High Dose

oral tablet

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 ]

Central Contacts and Locations

Locations

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Synapse Clinical Trials

Recruiting

Cerritos, California, United States, 80703

Contacts

Synergy Research Center

Recruiting

Lemon Grove, California, United States, 92064

Contacts

Cenexel CNS

Recruiting

Los Alamitos, California, United States, 90720

Contacts

NeuroBehavioral Hospitals of the Palm Beaches - South

Recruiting

Boynton Beach, Florida, United States, 33426

Contacts

Cenexel RCA

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Principal Investigator

954-990-7649e.gomez@cenexel.com

Cenexel ACMR

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Principal Investigator

404-881-5800e.barron@cenexel.com

Cenexel iResearch Atlanta

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Cenexel CBH

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63125

Contacts

Cenexel HRI

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Principal Investigator

856-452-9901ecohen@hritrials.com

Neuro-Behavioral Clinical Research

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Community Clinical Research

Recruiting

Austin, Texas, United States, 78754

Contacts

More Information

Sponsor

Kynexis B.V.

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Schizophrenia
  • Cognitive Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kynexis B.V. on 2026-06-23.