A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
Recruiting · NCT07191483 · Interventional (participants receive a specific treatment) · Lead sponsor: Kynexis B.V.
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
15 locations listed across 10 US states.
- Woodland International Research Group - Little Rock, Arkansas, United States
- Synapse Clinical Trials - Cerritos, California, United States
- Synergy Research Center - Lemon Grove, California, United States
- Cenexel CNS - Los Alamitos, California, United States
- NeuroBehavioral Hospitals of the Palm Beaches - South - Boynton Beach, Florida, United States
- Cenexel RCA - Hollywood, Florida, United States
- Segal Trials - Miami Lakes, Florida, United States
- Cenexel ACMR - Atlanta, Georgia, United States
- Cenexel iResearch Atlanta - Decatur, Georgia, United States
- Uptown Research Institute - Chicago, Illinois, United States
- Cenexel CBH - Gaithersburg, Maryland, United States
- Arch Clinical Trials - St Louis, Missouri, United States
- Cenexel HRI - Marlton, New Jersey, United States
- Neuro-Behavioral Clinical Research - North Canton, Ohio, United States
- Community Clinical Research - Austin, Texas, United States