NCT06346509已完成1 期
A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study of PORT-77 Administered Orally to Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II)
研究概览
简要总结
A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All healthy adult participants must be willing and able to follow protocol-specified assessments.
- •Healthy based on no clinically significant medical history, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs), as deemed by the Principal Investigator (PI) or designee.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
- •Participation in another clinical study within 60 days or within 10 half-lives (if known), prior to the first dosing, whichever is longer, or previous participation in another PORT 77 study or study part.
研究组 & 干预措施
Placebo
Placebo Comparator
Healthy adult participants will receive matching placebo.
干预措施: Placebo (Drug)
PORT-77
Experimental
Healthy adult participants will receive PORT 77.
干预措施: PORT-77 (Drug)
结局指标
主要结局
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II)
时间窗: Day 21
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
时间窗: Day 8
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)
时间窗: Day 21
次要结局
- Plasma concentration of a single-dose of PORT-77 (Part I)(Day 8)
- Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)(Day 8)
- Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)(Day 4)
- Plasma concentration of the steady-state of PORT-77 (Part II)(Day 21)
- Evaluate effects of single doses of PORT-77 on ECG parameters (Part II)(Day 21)
- Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III)(Day 21)
- Plasma concentration of the steady-state of PORT-77 (Part II and III)(Day 21)
研究者
研究点 (2)
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