A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)
Phase 1
Completed
- Conditions
- HTLV-1-Associated Myelopathy (HAM)
- Interventions
- Biological: MT-3921Biological: Placebo
- Registration Number
- NCT05240612
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
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
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Exclusion Criteria
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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT-3921 MT-3921 Intravenous (IV) Placebo Placebo Intravenous (IV)
- Primary Outcome Measures
Name Time Method Percentage of subjects with adverse reactions 36 weeks Serum concentrations of MT-3921 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 36 weeks CSF concentrations of MT-3921 PK samples will be collected at 2, 4, 12, 24 weeks post-dose.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan