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

Ki vehet részt

• 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

Ki nem vehet részt

• Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
• 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 or presence of malignancy within the last 3 years prior to screening
• Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
• History of anaphylaxis or clinically significant allergic reactions to any medication
• Subjects with current SARS-CoV-2 infection (COVID-19)
• Psychoactive substance use disorder
• Additional screening criteria check may apply for qualification:
• Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
• Penetrating spinal cord injuries
• Complete transection of the spinal cord
• Subjects with hereditary fructose intolerance
• Female subjects who are pregnant or lactating