NCT00406016已完成1 期
A Multi-center, Open-label, Cohort Study to Assess Feasibility, Acute Safety, Tolerability and Pharmacokinetics of 4 Dose Regimens of Continuous Intrathecal ATI355 Infusion and Two Regimen of Repeated Intrathecal Bolus Injections in Acute Spinal Cord Injury Paraplegic and Tetraplegic Patients
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
- Novartis
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits.
研究概览
简要总结
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: ATI355 (Drug)
结局指标
主要结局
Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits.
时间窗: 1 year
次要结局
- Immunogenicity of ATI355 in acute spinal cord injury patients up to one year.(1 year)
- Early potential signal of efficacy by the American Spinal Cord Injury Association (ASIA) protocol and pharmacodynamic changes assessed by electrophysiology tests for up to one year.(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05835986Hoffmann-La Roche70
进行中（未招募）
1 期
A Study of AP505 Injection in Patients With Advanced Malignant Solid TumorsAdvanced Solid TumorsNCT06723964AP Biosciences Inc.35
已完成
1 期
Study of TAK-733 in Adult Patients With Advanced Nonhematologic MalignanciesAdvanced Non-hematologic MalignanciesAdvanced Metastatic MelanomaNCT00948467Millennium Pharmaceuticals, Inc.51
招募中
1 期
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)Advanced Solid TumorMetastatic Solid TumorSoft Tissue Sarcoma (STS)Platinum-resistant Ovarian Cancer (PROC)Hepatocellular Carcinoma (HCC)Colorectal Cancer (CRC)HER2 Negative Breast CancerRenal Cell Carcinoma (RCC)Cutaneous MelanomaNCT05824975GI Innovation, Inc.358
已完成
1 期
A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid TumorsNeoplasmsNCT02004106Hoffmann-La Roche110