NCT05240612

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HTLV-1-Associated Myelopathy (HAM)

Interventions

Type	Name	Description
BIOLOGICAL	MT-3921	Solution for infusion; Intravenous (IV)
BIOLOGICAL	Placebo	Solution for infusion; Intravenous (IV)

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-09-14
• Completion: 2023-12-28
• First posted: 2022-02-15
• Last updated: 2024-01-29

Locations

1 site across 1 country: Japan