NCT00891241已完成1 期
A Multi-Center, Single Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
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
- 12
- 试验地点
- 2
- 主要终点
- Safety of LMI 1195 in terms of treatment-related adverse events
研究概览
简要总结
The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 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
Cohort 1
Experimental
Healthy Population
干预措施: LMI 1195-101 (Drug)
Cohort 2
Experimental
Heart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement
干预措施: LMI 1195-101 (Drug)
结局指标
主要结局
Safety of LMI 1195 in terms of treatment-related adverse events
时间窗: 14 days
Number of study subjects exhibiting treatment-related adverse events
次要结局
- Radiation Dosimetry of a single dose of LMI 1195(2 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)Parkinson's DiseaseNCT04651153UCB Biopharma SRL62
招募中
1 期
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT06211647Ruimin Wang20
招募中
1 期
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT06197139Xinlu Wang20
已完成
1 期
A Study of LY3079514 in Healthy ParticipantsHealthy VolunteersNCT02242903Eli Lilly and Company48
已完成
1 期
A Study to Assess Safety and Tolerability of GS1-144 in Healthy VolunteersVasomotor SymptomsAdult Healthy VolunteersNCT06204250Changchun GeneScience Pharmaceutical Co., Ltd.86