A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL151 in subjects with Parkinson's disease.
详细描述
This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the trial was transferred to Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive
- •Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H&Y Stage I, II, or III.
- •Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific study assessments
排除标准
- •Any history of clinically significant asthma, chronic obstructive pulmonary disease, or emphysema within 5 years of screening, or other clinically significant pulmonary disease within 6 months of screening
- •Abnormal Vitals including Respiratory Rate, Body Temperature, Blood Pressure, and Pulse Rate
- •Pulmonary Function Tests (PFTs) (FVC <60% predicted, FEV1 <50% predicted, FEV1:FVC ratio <0.6, DLCO <70% predicted)
- •Clinically significant neurologic disorder other than Parkinson's disease, including history of stroke within 12 months of screening, cognitive impairment, seizure within 5 years of screening, or head trauma with loss of consciousness within 6 months of screening
- •Montreal Cognitive Assessment (MoCA) score of <24 at screening
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
DNL151 Low Dose
干预措施: DNL151 (Drug)
DNL151 Mid Dose
干预措施: DNL151 (Drug)
DNL151 High Dose
干预措施: DNL151 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Randomization to Day 42
Number of Subjects with vital sign abnormalities
时间窗: Randomization to Day 42
Number of Subjects with clinically significant neurological examination abnormalities
时间窗: Randomization to Day 42
Number of Subjects with laboratory test abnormalities
时间窗: Randomization to Day 42
Number of Subjects with electrocardiogram (ECG) abnormalities
时间窗: Randomization to Day 42
次要结局
- Pharmacodynamic measure of pS935 in whole blood(Randomization to Day 28)
- Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151(Randomization to Day 28)
- Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151(Randomization to Day 28)
- Pharmacodynamic measure of pRab10 in PBMCs(Randomization to Day 28)
- Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151(Randomization to Day 28)
- Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151(Randomization to Day 28)
- Pharmacokinetic measure of CSF concentrations of DNL151(Randomization to Day 28)