A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects with Acute Spinal Cord Injury

About this Study

This study aims to investigate the safety, tolerability, pharmacokinetics of single ascending dose of
MT-3921 in subjects with acute spinal cord injury.

Sponsor Protocol ID:MT-3921-G01
IRB Number:2019-0331
Actively Enrolling
Phase 1
February 21, 2020
Eligibility Criteria
18 years old
65 years old
Both Male and Female

Inclusion CriteriaAble to understand the English language and provide English-language written informed consent from subjects, an impartial witness (for a subject who is physically unable to sign the informed consent form, but able to provide his/her consent by some other means [e.g., speaking, nodding, blinking], or the subject’s legally authorized representative (LAR) (for a subject who lacks capacity to consent for him/herself [e.g., a subject without mental capacity to consent]), prior to beginning any study procedures

 Traumatic acute spinal cord injury subjects who can receive MT-3921 within 72 hours from the time of the injury

Willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing informed consent 

Both female and male subjects of childbearing potential must agree to the use of contraception or abstinence during the study 

Exclusion CriteriaAny other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the Investigator, may increase the risks associated with study participation, and would preclude successful participation in the study

 Participation in any clinical trial of a new chemical entity within 12 weeks prior to screening period

Subjects who are human immunodeficiency virus (HIV), hepatitis virus B (HBV) or hepatitis virus C (HCV) positive

History or presence of malignancy within the last 5 years prior to screening, except subjects who have been treated successfully with no recurrence for >1 year of basal cell or squamous cell carcinoma of the skin or in-situ cervical cancer 

Pregnant or nursing women

Participating Locations
Pavilion - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jennifer Lowery
Phone Number: 601-496-7814
Email: jslowery@umc.edu
Principal Investigator:Washington, Chad W, M.D.
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