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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-3921 | Experimental | Intravenous, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3921 Low dose | Biological | MT-3921 Low dose, intravenous, single dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with adverse events within 6 months after single injection of MT-3921 | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Additional screening criteria check may apply for qualification:
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Clinical Development, | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95816 | United States | ||
| Northwestern University / Shirley Ryan Ability LAB (SRALAB) |
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| 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. | 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. | 6 months post-dose |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87131 | United States |
| Carolinas Healthcare System / Atrium Health | Charlotte | North Carolina | 28203 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| VA Commonwealth Univ. School of Medicine | Richmond | Virginia | 23298 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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