NCT07020819招募中3 期
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of a Single Dose of Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (GBS) (FORWARD Study)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)
研究概览
简要总结
The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.
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
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS.
- •Onset of GBS-related weakness ≤10 days before start of infusion on Day 1
- •GBS-disability score (DS) score of 3, 4, or 5 at screening and before start of infusion on Day
排除标准
- •Previous or intended treatment with either plasma exchange or IV immunoglobulin for GBS.
- •Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
- •Other protocol-defined criteria may apply.
研究组 & 干预措施
Tanruprubart
Experimental
Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.
干预措施: Tanruprubart (Drug)
结局指标
主要结局
Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)
时间窗: Up to Day 15
Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart
时间窗: Up to Day 15
次要结局
- Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum(Baseline up to Day 15)
- Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1(Baseline, Week 1)
研究者
研究点 (13)
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