A Clinical Pharmacological Study of MT-3921 in Subjects With Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)

Trial Information
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
20
Healthy Volunteers:
No

• 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

Where is this trial taking place?
Other Locations
Japan
St. Marianna University Hospital
Recruiting
Kawasaki-shi
Who do I contact about this trial?
Primary
Clinical Trials Information Desk, to prevent miscommunication,
cti-inq-ml@ml.mt-pharma.co.jp
please email:
When is this trial taking place?
Start Date: May 2, 2022
Estimated Completion Date: December 2023
How many participants will be in this trial?
Target number of participants: 15
What treatment is being studied in this trial?
Experimental: MT-3921
Intravenous (IV)
Placebo Comparator: Placebo
Intravenous (IV)
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov

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