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

NCT05240612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-01-29

No results posted yet for this study

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

BIOLOGICAL

MT-3921

Solution for infusion; Intravenous (IV)

BIOLOGICAL

Placebo

Solution for infusion; Intravenous (IV)

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • General Manager · Mitsubishi Tanabe Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2023-09-14
Completion
2023-12-28

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240612 on ClinicalTrials.gov