NCT06683612已完成1 期
A Phase 1b, Open-label Study of PIPE-791 to Determine Brain and Lung Lysophosphatidic Acid Receptor 1 (LPA1) Occupancy, by [18F] PIPE-497 PET Imaging in Healthy Volunteers, Volunteers With Progressive Multiple Sclerosis, and Volunteers With Idiopathic Pulmonary Fibrosis
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
- 16
- 试验地点
- 1
- 主要终点
- LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan.
研究概览
简要总结
This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients.
Participants will:
- Take a single dose of the study drug
- Give many samples of blood and urine
- Have multiple PET scans
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy volunteers, brain PET imaging
Experimental
干预措施: PIPE-791 (Drug)
Healthy volunteers, lung PET imaging
Experimental
干预措施: PIPE-791 (Drug)
Volunteers with PrMS
Experimental
干预措施: PIPE-791 (Drug)
Volunteers with IPF
Experimental
干预措施: PIPE-791 (Drug)
结局指标
主要结局
LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan.
时间窗: Baseline to up to 28 days post-dose
LPA1 occupancy as determined by regional total volume of distribution (VT) at each lung scan.
时间窗: Baseline to up to 28 days post-dose
次要结局
- Pharmacokinetics (PK): blood concentration levels of PIPE-791(Baseline to up to 28 days post-dose)
- The relationship between PIPE-791 plasma concentration and brain and lung LPA1 occupancy.(Baseline to up to 28 days post-dose)
- The PIPE-791 EC50 (i.e., the plasma concentration of PIPE-791 associated with 50% occupancy of LPA1) in the brain and lungs.(Baseline to up to 28 days post-dose)
- Safety and tolerability: Treatment-Emergent Adverse Events (TEAE)(Baseline to up to 32 days post-dose)
研究者
研究点 (1)
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