A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Safety of PN-235
研究概览
简要总结
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect of food study.
详细描述
Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses.
Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion.
In total, approximately 102 subjects will participate.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Part 1 blinded, Part 2 blinded, Part 3 unblinded
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
- •Subjects must have BMI between 18 and 32
- •Subjects must be non-smokers or social smokers
- •Subjects must comply with contraception requirements
- •Subjects must be willing to consume meals provided by the clinical center
排除标准
- •Subject must not have history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
- •Subjects must not have history of surgical resection of the stomach, small or large intestine
- •Subjects must not have fever or symptomatic viral or bacterial infection within 2 weeks of screening
- •Subjects must not have corrected QT greater than 450 msec in males and 470 msec in females
- •Subjects must not test positive for Hepatitis C or B at Screening
- •Subjects must refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
研究组 & 干预措施
Single Dose
Single dose administration
干预措施: PN-235 (Drug)
Single Dose
Single dose administration
干预措施: Placebo (Drug)
Multiple Dose
Multiple dose administration
干预措施: PN-235 (Drug)
Multiple Dose
Multiple dose administration
干预措施: Placebo (Drug)
Solid Dose Comparison
Solid dose administartion
干预措施: PN-235 (Drug)
结局指标
主要结局
Safety of PN-235
时间窗: 10 days
Number and severity of Adverse Events
次要结局
- Pharmacokinetics (PK) of PN-235 in plasma(10 days)
- Area Under the Concentration (AUC) of PN-235(10 days)