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NCT07191483 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
A Phase 2 study of Cognitive Impairment Associated With Schizophrenia (CIAS), sponsored by Kynexis B.V..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 13
- Study locations
NCT07191483 is a Phase 2 study of Cognitive Impairment Associated With Schizophrenia (CIAS) that is actively recruiting participants, run by Kynexis B.V.. The registered enrollment target is 150 participants. The trial reports 13 study locations across 10 states.
The verdict
NCT07191483, a Phase 2 study of Cognitive Impairment Associated With Schizophrenia (CIAS), is actively recruiting participants, sponsored by Kynexis B.V..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 13
- Study locations
Study Summary
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 Studied
Interventions
- OTHER Placebo
- DRUG KYN-5356 low dose
- DRUG KYN-5356 Medium Dose
- DRUG KYN-5356 High Dose
Study Locations (13)
California
- Synergy Research Center - Lemon Grove
- Cenexel CNS - Los Alamitos
Florida
- Cenexel RCA - Hollywood
- Segal Trials - Miami Lakes
Georgia
- Cenexel ACMR - Atlanta
- Cenexel iResearch Atlanta - Decatur
Arkansas
- Woodland International Research Group - Little Rock
Illinois
- Uptown Research Institute - Chicago
Maryland
- Cenexel CBH - Gaithersburg
Missouri
- Arch Clinical Trials - St Louis
New Jersey
- Cenexel HRI - Marlton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07191483
The ClinicalTrials.gov registry entry for NCT07191483 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kynexis B.V., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cognitive Impairment Associated With Schizophrenia (CIAS) appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT07191483 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT07191483 about?
NCT07191483 is a clinical study titled "A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia". 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...
What is the current status of trial NCT07191483?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-08-27. Estimated completion is 2026-12.
What conditions does trial NCT07191483 study?
This clinical trial studies the following conditions: Cognitive Impairment Associated With Schizophrenia (CIAS).
What interventions are being tested in trial NCT07191483?
The interventions under investigation include: Placebo (OTHER), KYN-5356 low dose (DRUG), KYN-5356 Medium Dose (DRUG), KYN-5356 High Dose (DRUG).
Who is sponsoring clinical trial NCT07191483?
This trial is sponsored by Kynexis B.V., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07191483 being conducted?
This trial has 13 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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