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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
oral tablet
Oral tablet
oral tablet
oral tablet
Woodland International Research Group
Little Rock, Arkansas, United States
RECRUITINGSynergy Research Center
Lemon Grove, California, United States
RECRUITINGCenexel CNS
Los Alamitos, California, United States
RECRUITINGCenexel RCA
Hollywood, Florida, United States
RECRUITINGSegal Trials
Miami Lakes, Florida, United States
RECRUITINGCenexel ACMR
Atlanta, Georgia, United States
RECRUITINGCenexel iResearch Atlanta
Decatur, Georgia, United States
RECRUITINGUptown Research Institute
Chicago, Illinois, United States
RECRUITINGCenexel CBH
Gaithersburg, Maryland, United States
RECRUITINGArch Clinical Trials
St Louis, Missouri, United States
RECRUITING...and 3 more locations
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)
Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score
Time frame: 28 days
Cmax
Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28
Time frame: 28 days
AUCtau
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
Time frame: 28 Days
Tmax
Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28
Time frame: 28 Days
Ctrough
Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28
Time frame: 28 Days
Terminal half-life (t1/2)
Terminal half-life (t1/2) after the last dose on Day 28 for KYN-5356 and relevant KYN-5356 metabolites
Time frame: 28 Days
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