NCT07034183招募中1 期
A First-in-Human Study of PRD001 in Healthy Participants, Assessment of Safety, Tolerability and Pharmacokinetics of Single/Multiple Doses
PRD Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年6月19日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of PRD001 in healthy participants and to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of PRD001 in participants with borderline/mild hyper-LDL-cholesterolemia and mild fatty liver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
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.
- •Part 1B 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
- •All parts
- •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.
研究组 & 干预措施
Part 1A: Single Ascending Dose
Experimental
干预措施: PRD001 (Drug)
Part 1A: Single Ascending Dose
Experimental
干预措施: Placebo (Drug)
Part 1B: Dietary effects
Experimental
干预措施: PRD001 (Drug)
Part 2A: 14 days Multiple Ascending Dose
Experimental
干预措施: PRD001 (Drug)
Part 2A: 14 days Multiple Ascending Dose
Experimental
干预措施: Placebo (Drug)
Part 2B: 28 days Multiple Ascending Dose
Experimental
干预措施: PRD001 (Drug)
Part 2B: 28 days Multiple Ascending Dose
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
时间窗: 42 days (treatment period: 28 days, observation period: 14 days)
Measured as count of events.
次要结局
未报告次要终点
研究者
研究点 (1)
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