NCT07016516已完成1 期
A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Doses Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRT-064040 Nasal Spray in Healthy Adult Subjects
Sichuan Purity Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
This trial is a Phase I, single-center, randomized, double-blind, placebo-controlled study conducted in healthy Chinese adult subjects.
The purpose of this study is to learn about:
- Safety and tolerability of PRT-064040 nasal spray in healthy adult subjects.
- Pharmacokinetics after single and multiple dose of PRT-064040 nasal spray in healthy Chinese adult subjects.
This study is divided into two parts:
- Eligible subjects in Part A will receive a single dose of PRT-064040 nasal spray or placebo.
- Eligible subjects in Part B will receive multiple doses of PRT-064040 nasal spray or placebo, administered once daily (QD) for a total of 7 consecutive days.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female Chinese adults aged ≥18 years and ≤55 years.
- •Body Mass Index of 18 to 28 kg/m^2; and a total body weight ≥50 kg for males and ≥45 kg for females.
排除标准
- •History of allergy to any medications, foods, or other substances.
- •History or presence of any severe diseases that are considered clinically significant by the investigator.
- •Any clinically significant abnormal laboratory test results or positive test.
- •Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
- •Standard 12-Lead Electrocardiogram that demonstrates clinically relevant abnormalities.
- •Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
- •Positive urine drug screen, alcohol breath test, or nicotine test.
- •History of significant alcohol abuse or drug abuse.
- •Donation or loss of blood of approximately 400 mL or more within 3 months prior to dosing.
- •Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.
研究组 & 干预措施
Single dose of PRT-064040 nasal spray
Experimental
干预措施: PRT-064040 nasal spray (Drug)
Single dose of Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Multiple doses of PRT-064040 nasal spray
Experimental
干预措施: PRT-064040 nasal spray (Drug)
Multiple doses of Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: From first dose to maximum of 2 days post last dose administration
次要结局
- Pharmacokinetic Parameters: Cmax(Up to 2 days post last dose administration)
- Pharmacokinetic Parameters: Tmax(Up to 2 days post last dose administration)
- Pharmacokinetic Parameters: AUC(Up to 2 days post last dose administration)
- Pharmacokinetic Parameters: Half life(Up to 2 days post last dose administration)
研究者
研究点 (1)
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