The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
MT-3921 Low dose, intravenous, single dosing
UC Davis Medical Center
Sacramento, California, United States
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
Chicago, Illinois, United States
Carle Foundation Hospital
Percentage of subjects with adverse events within 6 months after single injection of MT-3921
Time frame: 6 Months
Pharmacokinetic (PK) profile (Cmax)
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time frame: 6 months post-dose
PK profile (tmax)
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time frame: 6 months post-dose
PK profile (t½)
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time frame: 6 months post-dose
PK profile (AUC)
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time frame: 6 months post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 3 more locations