Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Inclusion Criteria: Additional screening criteria check may apply for qualification:

- Provide written informed consent prior to beginning any study procedures

- Cervical spinal cord injury that meet all of the following criteria:

- Classified as AIS A, AIS B or AIS C

- ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7)

- UEMS ≤28 at Screening

- Body mass index (BMI) <40

Exclusion Criteria: Additional screening criteria check may apply for qualification:

- Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations

- Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25

- Penetrating spinal cord injuries

- Complete transection of the spinal cord

- 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

- History of anaphylaxis or clinically significant allergic reactions to any medication

- History or presence of malignancy within the last 3 years prior to screening

- Subjects with current SARS-CoV-2 infection (COVID-19)

- Subjects with hereditary fructose intolerance

- Psychoactive substance use disorder

- Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening

- Female subjects who are pregnant or lactating

Conditions:
• Spinal Cord Injuries
• Wounds and Injuries