NCT06822517终止1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease.
The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose.
Approximately 30 patients will be randomized into 1 of the 2 treatment arms.
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 to 90 years of age, inclusive.
- •Body weight and body mass index (BMI) within the range of 100 to 265 pounds (45 to 120 kg) and 18 to 34 kg/m2 (inclusive), respectively.
- •A diagnosis of idiopathic PD according to United Kingdom (UK) Brain Bank or Movement Disorder Society (MDS) criteria with bradykinesia and ≥ 1 additional cardinal sign of PD (e.g., resting tremor, rigidity).
- •A diagnosis of PD for ≤ 7 years at Screening.
- •A modified Hoehn & Yahr stage 1 to 2.
- •If presently receiving treatment for PD, must be on a stable dose for ≥ 2 weeks prior to dosing, with no expected change in this regimen for the duration of the study.
- •If presently taking any non-PD concomitant medications, must be on a stable dose for ≥ 2 weeks prior to dosing.
排除标准
- •Any clinically significant abnormality at Screening
- •A positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV) 1/2 at Screening.
- •A significant neurological disease affecting the central nervous system, other than PD, that may affect cognition or ability to complete the study, including but not limited to dementias, severe and repetitive past (up to 5 years) head trauma, normal pressure hydrocephalus, or epilepsy or recurrent seizures (except febrile childhood seizures), as determined by the investigator.
- •Current serious or unstable illnesses, that, in the investigator's opinion, could compromise patient safety and ability to comply with study procedures, or has a life expectancy of < 24 months.
- •A history of suicidal ideation or previous suicide attempt in the 12 months prior to Screening or is clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the C-SSRS.
- •A contraindication (e.g., current use of anticoagulants) that would prohibit a lumbar puncture (LP).
- •Currently enrolled in any other interventional clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study, as assessed by the investigator.
- •Has participated in a clinical trial involving an investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing.
- •Has levodopa-induced dyskinesias lasting for > 25% of waking day or dyskinesias interfering with many daily activities.
- •Has dysphagia to the extent that it would affect the patient's ability to swallow the investigational medicinal product (IMP).
- •Has a parkinsonian syndrome, including atypical parkinsonism.
- •Is a known carrier (i.e., confirmed by historical medical documentation) of familial PD genes.
研究组 & 干预措施
VENT-02 Dose 1
Experimental
干预措施: VENT-02 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Baseline to Follow-up Visit (Day 35)
Number of treatment-emergent adverse events (TEAEs) with VENT-02 treatment compared to placebo
次要结局
- Concentrations of biomarkers(Baseline to Day 28)
- Concentrations of VENT-02 in plasma and CSF(Baseline to Day 28)
研究者
研究点 (1)
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