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

ClinicalTrials.gov ID: NCT07191483

Public ClinicalTrials.gov record NCT07191483. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 13, 2026, 7:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07191483
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Kynexis B.V.; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

Cognitive Impairment Associated With Schizophrenia (CIAS)

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 26, 2025
Primary completion: Sep 30, 2026
Completion: Nov 30, 2026
Last update posted: Jun 22, 2026

2025 – 2026

United States locations

U.S. sites: 15
U.S. states: 10
U.S. cities: 15

Facility	City	State	ZIP	Site status
Woodland International Research Group	Little Rock	Arkansas	72211	Recruiting
Synapse Clinical Trials	Cerritos	California	80703	Recruiting
Synergy Research Center	Lemon Grove	California	92064	Recruiting
Cenexel CNS	Los Alamitos	California	90720	Recruiting
NeuroBehavioral Hospitals of the Palm Beaches - South	Boynton Beach	Florida	33426	Recruiting
Cenexel RCA	Hollywood	Florida	33024	Recruiting
Segal Trials	Miami Lakes	Florida	33016	Terminated
Cenexel ACMR	Atlanta	Georgia	30331	Recruiting
Cenexel iResearch Atlanta	Decatur	Georgia	30030	Recruiting
Uptown Research Institute	Chicago	Illinois	60640	Recruiting
Cenexel CBH	Gaithersburg	Maryland	20877	Recruiting
Arch Clinical Trials	St Louis	Missouri	63125	Recruiting
Cenexel HRI	Marlton	New Jersey	08053	Recruiting
Neuro-Behavioral Clinical Research	North Canton	Ohio	44720	Recruiting
Community Clinical Research	Austin	Texas	78754	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07191483, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 22, 2026 · Synced Sep 13, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07191483 live on ClinicalTrials.gov.

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