NCT01189422终止1 期
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus
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
- MacroGenics
- 入组人数
- 1
- 主要终点
- Dose regimen
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
- •Diagnosis of type 1 diabetes mellitus
- •Currently receiving insulin therapy
- •Detectable fasting or stimulated C-peptide level at screening
- •One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies
排除标准
- •Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
- •Previous treatment with monoclonal antibody
- •Current treatment with oral antidiabetic agents
- •Evidence of active infection
研究组 & 干预措施
Segment 1: 3 Arms
Experimental
干预措施: teplizumab or placebo (Drug)
Segment 2: 4 Arms
Experimental
干预措施: teplizumab or placebo (Drug)
结局指标
主要结局
Dose regimen
时间窗: 91 days
Define and evaluate dose regimen based on AEs, PD response and drug levels.
次要结局
未报告次要终点
研究者
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