A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of GZ402668 in Men and Women With Progressive Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent adverse events
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in men and women with progressive multiple sclerosis.
Secondary Objectives:
To assess in men and women with progressive multiple sclerosis:
- The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.
- The pharmacodynamic (PD) response to GZ402668 after a single SC dose.
详细描述
The total study duration from screening for a patient can be approximately up to 8 weeks. Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a 4 year safety follow-up study for continued safety observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 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
GZ402668
Dose 1 (up to a maximum optional Dose 2) will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
干预措施: GZ402668 (Drug)
GZ402668
Dose 1 (up to a maximum optional Dose 2) will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
干预措施: Acyclovir (Drug)
Placebo
A dose of matching placebo will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
干预措施: Placebo (Drug)
Placebo
A dose of matching placebo will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
干预措施: Acyclovir (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events
时间窗: 4 weeks
次要结局
- Number of participants with anti-drug antibodies(4 weeks)
- Assessment of PK parameter: area under curve (AUC)(4 weeks)
- Number of participants with injection site reactions(4 weeks)
- Assessment of PK parameter: maximum concentration (Cmax)(4 weeks)
- Number of participants with lymphocyte depletion(4 weeks)