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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 28
- 主要终点
- To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
KYN-5356 low dose
KYN-5356 low dose, oral tablet for 28 days
干预措施: KYN-5356 low dose (Drug)
KYN-5356 medium dose
KYN-5356 medium dose, oral tablet for 28 days
干预措施: KYN-5356 Medium Dose (Drug)
Placebo
Placebo, oral tablet for 28 days
干预措施: Placebo (Other)
KYN-5356 high dose
KYN-5356 high dose, oral tablet for 28 days
干预措施: KYN-5356 High Dose (Drug)
结局指标
主要结局
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)
时间窗: 28 days
Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score
次要结局
- Cmax(28 days)
- AUCtau(28 Days)
- Tmax(28 Days)
- Ctrough(28 Days)
- Terminal half-life (t1/2)(28 Days)