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Keep this study
Lead
Tanabe Pharma America, Inc.
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
