NCT01541670终止1 期
A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
Baxalta now part of Shire23 个研究点 分布在 5 个国家目标入组 4 人开始时间: 2011年11月28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
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 23
- 主要终点
- Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent obtained from the subject
- •Males and females of age 18 years and older at the time of screening
- •Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria
- •Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening
- •Urine protein-to-creatinine ratio > 0.5 (mg/mg)
排除标准
- •Any significant health problem other than lupus or lupus nephritis
研究组 & 干预措施
Open-label Dose-Escalation Arm
Experimental
Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product
干预措施: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody (Drug)
结局指标
主要结局
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
时间窗: Week 21
次要结局
- Plasma pharmacokinetic parameters(Week 21)
研究者
研究点 (23)
Loading locations...
相似试验
招募中
1 期
Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for R/R MMMultiple MyelomaNCT05438394Peking University People's Hospital24
已完成
1 期
Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to HIV Uninfected AdultsHIV InfectionsNCT00384787National Institute of Allergy and Infectious Diseases (NIAID)90
招募中
早期 1 期
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid TumorsPancreatic NeoplasmsOther Solid TumorsNCT06577532Ruijin Hospital56
已完成
1 期
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite AllergyPerennial Allergic RhinoconjunctivitisAllergic AsthmaNCT00652223Cytos Biotechnology AG21
已完成
1 期
Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in AdultsSmallpoxNCT00079820Sanofi Pasteur, a Sanofi Company110