A Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Multiple Oral Doses of RDN-929 in Healthy Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of subjects with Clinical safety lab changes
研究概览
简要总结
Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males or postmenopausal or surgically sterile females age 55 - 85 years old.
- •Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and ECG recording
排除标准
- •Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN)
- •A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations
- •A clinically significant vital signs abnormality, as judged by the principal investigator
研究组 & 干预措施
RDN-929
low, medium and high dose of RDN-929 capsules
干预措施: RDN-929 oral capsule (Drug)
Placebo
Matching placebo capsules
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Number of subjects with Clinical safety lab changes
时间窗: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with adverse events
时间窗: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Physical exam findings
时间窗: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Heart rate changes
时间窗: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with Systolic blood pressure changes
时间窗: up to 9 weeks
Screening to end of study, up to 9 weeks
Number of subjects with 12 Lead ECG changes
时间窗: up to 9 weeks
Screening to end of study, up to 9 weeks
次要结局
- Maximum observed plasma concentration, Cmax(Day 1 to Day 28)
- Area Under the plasma and CSF concentration time curve, AUC(Day 1 to Day 28)