A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.
详细描述
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females
- •Aged 18 to 65 years, inclusive
- •Body mass index (BMI) of 18 to 32kg/m^2 inclusive at Screening
- •Non-smoker or no tobacco/nicotine usage with 30 days of Screening
排除标准
- •Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities
- •Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in
研究组 & 干预措施
Experimental: 1
干预措施: APN1125 (Drug)
Placebo Comparator: 2
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams
时间窗: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs
时间窗: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)
时间窗: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)
时间窗: 8 days
Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events
时间窗: 8 days
次要结局
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)(24 hours)
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)(24 hours)
- Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)(24 hours)
- Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)(24 hours)
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)(24 hours)
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast)(24 hours)
- Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)(24 hours)
- Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)(24 hours)
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)(24 hours)
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)(24 hours)
- Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)(24 hours)
- Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)(24 hours)