A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia

Официальное название

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

Обзор

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.

Вмешательства

• Препарат KYN-5356 low dose
  oral tablet
• Другое Placebo
  Oral tablet
• Препарат KYN-5356 Medium Dose
  oral tablet
• Препарат KYN-5356 High Dose
  oral tablet

Первичные конечные точки

• To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS) [Срок оценки: 28 days]

Вторичные конечные точки (5)

• Cmax [Срок оценки: 28 days]
• AUCtau [Срок оценки: 28 Days]
• Tmax [Срок оценки: 28 Days]
• Ctrough [Срок оценки: 28 Days]
• Terminal half-life (t1/2) [Срок оценки: 28 Days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Woodland International Research Group — Little Rock
• Synapse Clinical Trials — Cerritos
• Synergy Research Center — Lemon Grove
• Cenexel CNS — Los Alamitos
• NeuroBehavioral Hospitals of the Palm Beaches - South — Boynton Beach
• Cenexel RCA — Hollywood
• Segal Trials — Miami Lakes
• Cenexel ACMR — Atlanta
• … и ещё 7 центров

Идентификаторы

NCT: NCT07191483 · KYN5356-CL-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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