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

MT-3921-G01

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.

2020-04-19

2021-01-06

2021-01-06

Completed

Early phase I

3

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2023-05-15