Actively Recruiting
A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
Led by Kynexis B.V. · Updated on 2025-09-25
150
Participants Needed
13
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 as judged by the investigator
- Diagnosis of schizophrenia for at least 1 year before screening
- Currently on stable maintenance antipsychotic monotherapy for 2 months or more before screening, including any psychotropic medications
- Male or female aged 18 to 55 years
- Body mass index (BMI) between 18 and 40 kg/m2 inclusive
- Ability to comply with all study procedures as judged by the investigator
- Signed and dated informed consent before screening according to Good Clinical Practice
You will not qualify if you...
- Currently treated with more than one antipsychotic medication at the time of screening
- Score of 2 or higher on any item of the Modified Simpson-Angus Scale (mSAS) at screening
- Moderate to severe substance use disorder (except nicotine or caffeine, including alcohol)
- Evidence of unstable medical condition
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Synergy Research Center
Lemon Grove, California, United States, 92064
Actively Recruiting
3
Cenexel CNS
Los Alamitos, California, United States, 90720
Actively Recruiting
4
Cenexel RCA
Hollywood, Florida, United States, 33024
Actively Recruiting
5
Segal Trials
Miami Lakes, Florida, United States, 33016
Actively Recruiting
6
Cenexel ACMR
Atlanta, Georgia, United States, 30331
Actively Recruiting
7
Cenexel iResearch Atlanta
Decatur, Georgia, United States, 30030
Actively Recruiting
8
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
9
Cenexel CBH
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
10
Arch Clinical Trials
St Louis, Missouri, United States, 63125
Actively Recruiting
11
Cenexel HRI
Marlton, New Jersey, United States, 08053
Actively Recruiting
12
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
13
Community Clinical Research
Austin, Texas, United States, 78754
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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