jRCT2071250016招募中不适用
A phase 1 study of PRD001 in healthy participants: Part 1A - randomized, double-blind, placebo-controlled assessment of safety, tolerability and pharmacokinetics of single, ascending, oral doses with additional cohorts of Part 1B - effect of food on the pharmacokinetics of PRD001; Part 2A - randomized, double-blind, placebo-controlled assessment of safety, tolerability and pharmacokinetics of multiple, ascending, oral doses with expansion cohort of Part 2B - randomized, double-blind, placebo-controlled assessment of safety, pharmacodynamics and pharmacokinetics of multiple, oral doses in participants with borderline/mild hyper-LDL-cholesterolemia and mild fatty liver.
PRD Therapeutics Inc.0 个研究点目标入组 86 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 60age old under（—）
- 性别
- Male
入选标准
- •Part 1A and Part 2A
- •Healthy men aged between 18 and 45 years inclusive at the time of signing the informed consent form (ICF)
- •Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- •Individuals who are able to participate in Part 1B following Part 1A, and are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- •Individuals who have no clinically significant findings, are generally healthy and have no disease requiring medical treatment, based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening.
- •For Japanese participants in Part 1A and Part 2A, individuals whose parents and maternal and paternal grandparents are Japanese, and for Caucasian participants in Part 2A, individuals whose parents and maternal and paternal grandparents are Caucasian.
- •Individuals who receive PRD001 in Part 1A and complete all specified visit schedules.
- •Men aged between 18 and 60 years inclusive at the time of signing the ICF
- •Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- •Individuals who have no clinically significant findings, are generally healthy and have no disease requiring medical treatment (however, diet or exercise therapy is acceptable), based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening.
- •Individuals whose parents and maternal and paternal grandparents are Japanese.
- •Individuals who meet the following criteria:
- •i. Individuals with mild-hyper-LDL-cholesterolemia
- •ii. Individuals with mild hepatic steatosis
排除标准
- •Individuals with active, latent, or inadequately treated M. tuberculosis infection at screening who meet both of the following:
- •i. A positive result on the QuantiFERON-TB Gold test or an equivalent test
- •ii. Active tuberculosis infection that is untreated, inadequately treated, or currently being treated
- •Individuals with a history of human immunodeficiency virus (HIV) infection, syphilitic infection, hepatitis B or C at screening.
结局指标
主要结局
Treatment-emergent adverse events
Safety and tolerability based on treatment-emergent adverse events
Serious adverse events
Safety and tolerability based on serious adverse events
Vital signs
Safety and tolerability based on vital signs
Laboratory test results
Safety and tolerability based on laboratory test results
12-lead ECG
Safety and tolerability based on 12-lead ECG
次要结局
未报告次要终点
研究者
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