NCT05240612已完成1 期
A Clinical Pharmacological Study of MT-3921 in Subjects With Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percentage of subjects with adverse reactions
研究概览
简要总结
The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM).
Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.
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
- 20 Years 至 —（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:
- •Subjects aged 20 years or older on the day of consent
- •Subjects with a confirmed diagnosis of HAM according to the diagnostic algorithm of Practical Guideline for HAM 2019 on the day of consent
- •Subjects with an Osame's motor disability score (OMDS) of ≥4 and ≤6 at Screening and on the first day of the Treatment period (predose)
- •Subjects with no change in OMDS for at least 3 months before the day of consent
- •Subjects with a CSF concentration neopterin of ≥6 pmol/mL at Screening
- •Subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to ≤10 mg/day of prednisolone for at least 3 months before the day of consent
排除标准
- •Additional screening criteria check may apply for qualification:
- •Subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products
- •Subjects exhibiting or with a history of malignant tumor.
- •Subjects with adult T-cell leukemia/lymphoma (ATL) or those with positive HTLV-1 clonality test (Southern blot) at screening and suspected of having ATL
- •Subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament
- •Subjects with psychiatric disorders, epileptic seizures, or dementia.
- •Subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the Columbia Suicide Rating Scale (C-SSRS) at screening and/or on the first day of the Treatment period (predose)
- •Subjects exhibiting or with a history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
- •Subjects with the novel Coronavirus disease 2019 (COVID-19)
- •Subjects with severe illness
- •Male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product
- •Female subjects who are pregnant, lactating, or may be pregnant
- •Subjects who have received anti-repulsive guidance molecule (RGM) a antibody containing this investigational medical product
- •Subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent
研究组 & 干预措施
Placebo
Placebo Comparator
Intravenous (IV)
干预措施: Placebo (Biological)
MT-3921
Experimental
Intravenous (IV)
干预措施: MT-3921 (Biological)
结局指标
主要结局
Percentage of subjects with adverse reactions
时间窗: 36 weeks
Serum concentrations of MT-3921
时间窗: PK samples will be collected at predose, 1.5 hours, 2, 4, 8, 12, 20 (predose and 1.5 hours), 24, 36 weeks post-dose.
Percentage of subjects with adverse events
时间窗: 36 weeks
CSF concentrations of MT-3921
时间窗: PK samples will be collected at 2, 4, 12, 24 weeks post-dose.
次要结局
未报告次要终点
研究者
研究点 (1)
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