A Phase 1, FIH, Double-blind, Randomised Placebo-controlled Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of PA401, and the Effects of PA401 Following LPS Challenge, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects.
This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males aged 18 to 65 years
排除标准
- •Subjects with a clinically relevant medical history
结局指标
主要结局
Treatment Emergent Adverse Events
时间窗: up to 14 days post dose
Immunogenicity
时间窗: Up to 28 days post dose
Anti-drug antibody data
Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils
时间窗: 5.5 hours post dose
Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils
次要结局
- Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity(Up to 12 time-points up to 48 hours post dose)
- Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)(Up to 12 time-points up to 48 hours post dose)
- Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)(Up to 12 time-points up to 48 hours post dose)
- Pharmacokinetic Parameters: Terminal Half-life (t1/2)(Up to 12 time-points up to 48 hours post dose)
- Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils(5.5 hours post dose)