A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
详细描述
PN-881 will be administered in oral solution and tablet formulations, with dosing under fasting or fed conditions depending on the study part.
The study consists of five parts:
Part 1 - Single Ascending Dose (SAD): Randomised, double-blind, placebo-controlled Part 2 - Multiple Ascending Dose (MAD): Randomised, double-blind, placebo-controlled Part 3 - Tablet Formulation Comparison: Open-label, crossover design; participants will receive different oral tablet formulations Part 4 - Effect of Food: Open-label, crossover design to assess the effect of food on the pharmacokinetics of PN-881. Participants will receive PN-881 tablet formulations in fasted and fed conditions.
Part 5 - Dosing Frequency Comparison: Open-label, randomized study comparing once-daily and twice-daily dosing.
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
- Double (Participant, Investigator)
盲法说明
Part 1 & Part 2 is masked; Part 3, Part 4 and Part 5 are open label
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 male and female participants of non-childbearing potential, aged 18-65 years inclusive
- •Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening
- •Willing and able to comply with all study requirements and provide written informed consent
- •Male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose
排除标准
- •Clinically significant history or presence of cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases
- •History of neoplastic disease (except adequately treated non-melanoma skin cancer)
- •Positive test for hepatitis B, hepatitis C, or HIV at screening
- •History of substance abuse or recreational IV drug use within the past 2 years
- •Clinically significant infection or fever (>38°C) within 2 weeks prior to screening
- •Use of any prescription/non-prescription drugs or herbal supplements within 7 days or 5 half-lives before dosing (unless approved by investigator)
- •Supine blood pressure or ECG abnormalities outside protocol-defined ranges
- •Use of tobacco/nicotine products exceeding 5 cigarettes/day or 2 chews/day
- •Consumption of >21 alcohol units/week (males) or >14 units/week (females)
研究组 & 干预措施
PN-881 Oral Tablet Multiple Dose
PN-881 oral tablet multiple dose
干预措施: PN-881 Oral Tablet (Drug)
PN-881 Oral Solution Single Ascending Dose
PN-881 Oral Solution Single Ascending Dose
干预措施: PN-881 Oral Solution (Drug)
Placebo Oral Solution Single Ascending Dose
Placebo single ascending doses
干预措施: Placebo (Drug)
PN-881 Oral Solution Multiple Ascending Dose
PN-881 Multiple Ascending Doses
干预措施: PN-881 Oral Solution (Drug)
Placebo Oral Solution Multiple Ascending Dose
Placebo, multiple ascending doses
干预措施: Placebo (Drug)
PN-881 Oral Tablet Single Dose
PN-881 oral tablet single dose
干预措施: PN-881 Oral Tablet (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: Predose to 7 days after last dose
Evaluate the safety and tolerability of PN-881 in comparison to placebo after single and multiple doses in healthy subjects assessed for severity, seriousness, and relation to the investigational product.
次要结局
- Maximum observed plasma concentration (Cmax) of PN-881(48 hours following the first dose and the last dose)
- Maximum observed plasma concentration (Cmax) of PN-881(48 hours following the first dose and the last dose)
- Area under the plasma concentration-time curve (AUC) of PN-881(Predose to 48 hours after the first and last dose.)
- Levels of biomarker in serum(Day 1 Predose up to 48 hours post (last) dose)