A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 12
- 主要终点
- Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)
研究概览
简要总结
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Males or females (18-70 years of age; < 104 kg)
- •Capable of giving informed consent
- •Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
- •Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
- •Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.
排除标准
- •Certain specified co-morbidities (including pregnancy)
- •Taking certain proscribed medications
- •A medical regimen that has changed in the month prior to screening
- •Inability to undergo requisite MRI evaluations
- •Drug or alcohol abuse
- •Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.
研究组 & 干预措施
rHIgM22
Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).
干预措施: rHIgM22 (Drug)
Placebo
Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)
时间窗: Up to 180 days
Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).
次要结局
- The Expanded Disability Status Scale (EDSS)(Screening, specified time points up to 180 days post treatment)
- Immunogenicity profile of single ascending doses of rHIgM22(Specified time points up to 180 days post treatment)
- Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22(Pre-dose (day 1), specified time points up to 48 hours post treatment)
- Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22(Pre-dose (day 1), specified time points up to 48 hours post treatment)
- Half-life (T1/2) of single ascending doses of rHIgM22(Pre-dose (day 1), specified time points up to 48 hours post treatment)
- Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22(Pre-dose (day 1), specified time points up to 48 hours post treatment)