Spinal Cord Injury
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.
Detailed description
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.
Interventions
BIOLOGICALMT-3921 Low dose
MT-3921 Low dose, intravenous, single dosing
Sponsors
Tanabe Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with adverse events within 6 months after single injection of MT-3921 | 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) profile (Cmax) | 6 months post-dose | PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose. |
| PK profile (tmax) | 6 months post-dose | PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose. |
| PK profile (t½) | 6 months post-dose | PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose. |
| PK profile (AUC) | 6 months post-dose | PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose. |
Countries
United States
Outcome results
None listed