A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of DNL151 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under Section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by Sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening
- •In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements
- •Women of non-childbearing potential and men using contraceptive measures
排除标准
- •History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders
- •History of asthma, chronic obstructive pulmonary disease, or emphysema
- •Clinically significant neurologic disorder
- •History of stomach or intestinal surgery or resection
- •History of malignancy
研究组 & 干预措施
DNL151
Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days); Part C: Single-dose cohort; Part D: Additional multiple-dose cohort (28 days); Part E Multiple-ascending dose cohorts (14 days)
干预措施: DNL151 (Drug)
Placebo
Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days); Part C: Single-dose cohort; Part D: Additional multiple-dose cohort (28 days); Part E Multiple-ascending dose cohorts (14 days)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs
时间窗: Up to 42 days
PK parameter: Maximum observed concentration (Cmax) of DNL151 in plasma
时间窗: Up to 42 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL151 in plasma
时间窗: Up to 42 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL151 in plasma (single dosing only)
时间窗: Up to 42 days
PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL151 in plasma
时间窗: Up to 42 days
PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL151 in plasma (multiple dosing only)
时间窗: Up to 42 days
PK parameter: Apparent terminal elimination half-life (t1/2) of DNL151 in plasma
时间窗: Up to 42 days
次要结局
- Concentration of DNL151 in cerebrospinal fluid (CSF) (following selected single and multiple doses)(Up to 13 days)
- The pharmacodynamics of DNL151 in whole blood as measured by the percent change from baseline in pS935(Up to 42 days)