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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KYN-5356 low dose | Experimental | KYN-5356 low dose, oral tablet for 28 days |
|
| KYN-5356 medium dose | Experimental | KYN-5356 medium dose, oral tablet for 28 days |
|
| KYN-5356 high dose | Experimental | KYN-5356 high dose, oral tablet for 28 days |
|
| Placebo | Placebo Comparator | Placebo, oral tablet for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KYN-5356 low dose | Drug | oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Recruiting | Little Rock | Arkansas | 72211 | United States |
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| Other |
Oral tablet |
|
| KYN-5356 Medium Dose | Drug | oral tablet |
|
| KYN-5356 High Dose | Drug | oral tablet |
|
| 28 Days |
| Tmax | Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28 | 28 Days |
| Ctrough | Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28 | 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 | 28 Days |
| Synapse Clinical Trials | Recruiting | Cerritos | California | 80703 | United States |
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| Synergy Research Center | Recruiting | Lemon Grove | California | 92064 | United States |
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| Cenexel CNS | Recruiting | Los Alamitos | California | 90720 | United States |
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| NeuroBehavioral Hospitals of the Palm Beaches - South | Recruiting | Boynton Beach | Florida | 33426 | United States |
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| Cenexel RCA | Recruiting | Hollywood | Florida | 33024 | United States |
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| Segal Trials | Terminated | Miami Lakes | Florida | 33016 | United States |
| Cenexel ACMR | Recruiting | Atlanta | Georgia | 30331 | United States |
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| Cenexel iResearch Atlanta | Recruiting | Decatur | Georgia | 30030 | United States |
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| Uptown Research Institute | Recruiting | Chicago | Illinois | 60640 | United States |
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| Cenexel CBH | Recruiting | Gaithersburg | Maryland | 20877 | United States |
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| Arch Clinical Trials | Recruiting | St Louis | Missouri | 63125 | United States |
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| Cenexel HRI | Recruiting | Marlton | New Jersey | 08053 | United States |
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| Neuro-Behavioral Clinical Research | Recruiting | North Canton | Ohio | 44720 | United States |
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| Community Clinical Research | Recruiting | Austin | Texas | 78754 | United States |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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