A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Safety of PN-232
研究概览
简要总结
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that 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 crossover solid dose comparison and effect of food study.
详细描述
Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.
Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.
In total, approximately 84 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)
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 kg/m2
- •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
- •Subjects must be willing to attend required clinic visits
- •Subjects must be suitable candidates for study procedures
排除标准
- •Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
- •Subjects with a history of surgical resection of the stomach, small or large intestine
- •Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
- •Subjects with clinically significant laboratory abnormalities
- •Subjects with corrected QT greater than 450 msec in males and 470 msec in females
- •Subjects who test positive for Hepatitis C or B, or HIV at Screening
- •Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
- •Subjects who test positive for drugs of abuse or alcohol at Screening
研究组 & 干预措施
Single Dose
Single dose administration
干预措施: PN-232 (Drug)
Single Dose
Single dose administration
干预措施: Placebo (Drug)
Multiple Dose
Multiple dose administration
干预措施: PN-232 (Drug)
Multiple Dose
Multiple dose administration
干预措施: Placebo (Drug)
Solid Dose Comparison
Solid dose administration
干预措施: PN-232 (Drug)
结局指标
主要结局
Safety of PN-232
时间窗: 10 days
Number and Severity of Adverse Events
次要结局
- Peak concentration of PN-232 in plasma(10 days)
- Area under the Concentration (AUC) of PN-232(10 days)