NL-OMON48424已完成不适用
A two-part parallel group study to assess the safety, tolerability and pharmacokinetic (PK) profile of multiple oral doses of RDN-929 in healthy older adults and subjects with early symptomatic Alzheimer*s Disease - RDN-929-103 (CS0317)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult males or postmenopausal or surgically sterile females age 55 * 85 years
- •old for Part 1 and age 50-85 years old for Part 2, inclusive, at the time of
- •informed consent.
- •Body mass index (BMI) *18.0 kg/m2, <35.0 kg/m2.
- •Further inclusion criteria can be found in the protocol section 8.5.1.
排除标准
- •History or current evidence of any clinically significant cardiovascular,
- •endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic,
- •pulmonary, neurologic (except for diagnosis of AD in Part 2), renal, or other
- •major disease, as determined by the Investigator.
- •Any conditions that, in the opinion of the Investigator, would make the subject
- •unsuitable for enrollment or could interfere with the subject*s participation
- •in or completion of the study.
- •Further exclusion criteria can be found in the protocol section 8.5.2
研究者
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