NCT06556173已完成2 期
A Phase 2a, Single Site, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTX3232 in Participants With Early-Stage Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion
研究概览
简要总结
This is a study to understand if taking VTX3232 is safe in participants diagnosed with early stage idiopathic Parkinson's Disease (PD). Approximately 10 patients will take VTX3232 Dose A.
The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 7-day Pre-Baseline Period, a 28-day Open Label Treatment period (a participant receives active Dose A), and a 14-day Follow-Up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥ 40 years up to 80 years of age, inclusive, at the time of signing the informed consent, with BMI > 18.5 and < 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- •Diagnosis of idiopathic Parkinson's Disease between 0 and 60 months prior to screening.
- •Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV at screening.
- •Have not received prior treatment with deep brain stimulation (DBS).
- •If receiving treatment with symptomatic PD therapies, treatment must be stable. Note: The Medical Monitor should be contacted with any questions regarding concomitant therapies.
- •A female participant is eligible if they are of nonchildbearing potential
- •A male participant sexually active with a woman of child bearing potential is eligible if they agree to use contraception/barrier and refrain from donating sperm during the study and for at least 90 days after the last dose
排除标准
- •Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease.
- •A diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease; history of repeated head injury or traumatic brain injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
- •History of brain surgery.
研究组 & 干预措施
VTX3232 Dose A
Experimental
干预措施: VTX3232 (Drug)
结局指标
主要结局
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion
时间窗: Day 1 of treatment period through study completion, up to 6 weeks
Incidence of AEs and SAEs
次要结局
- Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28(Day 1 of treatment period to Day 28 of treatment period)
研究者
研究点 (2)
Loading locations...
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