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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Percentage of subjects with adverse events
Time frame: 36 weeks
Percentage of subjects with adverse reactions
Time frame: 36 weeks
Serum concentrations of MT-3921
Time frame: 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.
CSF concentrations of MT-3921
Time frame: PK samples will be collected at 2, 4, 12, 24 weeks post-dose.
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