NCT00616733已完成1 期
An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Safety and tolerability.
研究概览
简要总结
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)
- •Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months
- •Baseline EDSS score of 0 - 6.5
- •Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
排除标准
- •Primary progressive MS
- •Any medical condition that predisposes to immunocompromise
- •History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
- •Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
- •Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
- •Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
- •Treatment with interferon beta or glatiramer acetate within 2 months of study initiation
- •Prior treatment with natalizumab or rituximab
研究组 & 干预措施
1
Experimental
干预措施: CS-0777 tablets (Drug)
2
Experimental
干预措施: CS-0777 tablets (Drug)
3
Experimental
干预措施: CS-0777 tablets (Drug)
结局指标
主要结局
Safety and tolerability.
时间窗: 12 weeks, with 4 weeks to follow-up
次要结局
- Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)(12 weeks, with 4 weeks to follow up.)
研究者
相似试验
已完成
1 期
Safety,Tolerability and MTD KA2507 (HDAC6 Inhibitor) in Patients With Solid TumoursSolid Tumor, AdultNCT03008018Karus Therapeutics Limited20
终止
2 期
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal TransplantationKidney TransplantationNCT06365437ITB-Med LLC33
已完成
2 期
A Dose Escalation Study in de Novo Renal TransplantationKidney TransplantationNCT04311632ITB-Med LLC13
已完成
1 期
An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)Spinal Muscular AtrophyNCT01494701Biogen28
Unknown
1 期
Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid TumoursNeoplasmsNCT02314884Jiangsu Hansoh Pharmaceutical Co., Ltd.40