A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
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.
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
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 149 participants
Conditions and interventions
Interventions
- KYN-5356 low dose Drug
- Placebo Other
- KYN-5356 Medium Dose Drug
- KYN-5356 High Dose Drug
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 27, 2025 (Actual)
- Primary completion
- Sep 9, 2026 (Actual)
- Completion
- Sep 16, 2026 (Actual)
- Last update posted
- Oct 23, 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 | — |
| Synapse Clinical Trials | Cerritos | California | 80703 | — |
| Synergy Research Center | Lemon Grove | California | 92064 | — |
| Cenexel CNS | Los Alamitos | California | 90720 | — |
| NeuroBehavioral Hospitals of the Palm Beaches - South | Boynton Beach | Florida | 33426 | — |
| Cenexel RCA | Hollywood | Florida | 33024 | — |
| Segal Trials | Miami Lakes | Florida | 33016 | — |
| Cenexel ACMR | Atlanta | Georgia | 30331 | — |
| Cenexel iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Cenexel CBH | Gaithersburg | Maryland | 20877 | — |
| Arch Clinical Trials | St Louis | Missouri | 63125 | — |
| Cenexel HRI | Marlton | New Jersey | 08053 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Community Clinical Research | Austin | Texas | 78754 | — |
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 Oct 23, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07191483 live on ClinicalTrials.gov.