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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: MT-3921 Low dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-3921<br>Intravenous, single dose | Biological: MT-3921 Low dose<br>* MT-3921 Low dose, intravenous, single dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with adverse events within 6 months after single injection of MT-3921 |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |