NCT04096950已完成1 期
A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 26
- 主要终点
- Percentage of subjects with adverse events within 6 months after single injection of MT-3921
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.
详细描述
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Additional screening criteria check may apply for qualification:
- •Provide written informed consent prior to beginning any study procedures
- •Cervical spinal cord injury, ASIA impairment scale grade A, B, and C with the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological level of injury between C4 and C8
- •Male or female subjects aged between 18 and 65 years
- •Body mass index (BMI) <35
- •Has had stabilization surgery (if needed) following their SCI and prior to receiving MT-3921
排除标准
- •Additional screening criteria check may apply for qualification:
- •Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
- •Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
- •Penetrating spinal cord injuries
- •Traumatic transection of the spinal cord or spinal cord contusion size > 3 cm determined by MRI
- •Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
- •Subjects with HIV, HBV or HCV positive
- •Psychoactive substance use disorder
- •History or presence of malignancy within the last 5 years prior to screening
- •Pregnant or nursing women
- •Subjects with hereditary fructose intolerance
- •History of anaphylaxis or significant allergy
结局指标
主要结局
Percentage of subjects with adverse events within 6 months after single injection of MT-3921
时间窗: 6 Months
次要结局
- PK profile (t½)(6 months post-dose)
- PK profile (AUC)(6 months post-dose)
- Pharmacokinetic (PK) profile (Cmax)(6 months post-dose)
- PK profile (tmax)(6 months post-dose)
研究者
研究点 (26)
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