Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury

Completed · Phase 1

Conditions studied: Spinal Cord Injury

In brief

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.

Key facts

Study ID

NCT04096950

Run by

Tanabe Pharma America, Inc.

People needed

3

Starts

2020-04-19

Expected to finish

2021-01-06

Last updated by the study team

2023-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Additional screening criteria check may apply for qualification:
• Provide written informed consent prior to beginning any study procedures
• Cervical spinal cord injury, ASIA impairment scale grade A, B, and C with the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological level of injury between C4 and C8
• Male or female subjects aged between 18 and 65 years
• Body mass index (BMI) <35
• Has had stabilization surgery (if needed) following their SCI and prior to receiving MT-3921

You may not qualify if…

• Additional screening criteria check may apply for qualification:
• Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
• Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
• Penetrating spinal cord injuries
• Traumatic transection of the spinal cord or spinal cord contusion size > 3 cm determined by MRI
• Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
• Subjects with HIV, HBV or HCV positive
• Psychoactive substance use disorder
• History or presence of malignancy within the last 5 years prior to screening
• Pregnant or nursing women
• Subjects with hereditary fructose intolerance
• History of anaphylaxis or significant allergy

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Northwestern University / Shirley Ryan Ability LAB (SRALAB) — Chicago, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of New Mexico Hospital — Albuquerque, New Mexico, United States
• Carolinas Healthcare System / Atrium Health — Charlotte, North Carolina, United States
• Vidant Medical Center — Greenville, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• VA Commonwealth Univ. School of Medicine — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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