A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.
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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive
- •BMI 18.5 to <30 kg/m²
- •When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
排除标准
- •History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
- •History of malignancy
- •History of clinically significant stroke
- •History of cognitive impairment
- •Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding
研究组 & 干预措施
DNL919 (Healthy Participant)
干预措施: DNL919 (Drug)
Placebo (Healthy Participant)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
时间窗: Up to 45 days
次要结局
- PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf)(Up to 45 days)
- PK Parameter: Maximum concentration (Cmax) of DNL919 in serum(Up to 45 days)