Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)

Exclusion Criteria

• •1. Unable to obtain informed consent (either from the participant or from the participant's legally authorized representative \[LAR\])
• •2. Women who are breastfeeding (if unwilling to stop for the first 35 days of the study) or who are pregnant
• •3. Coma or significant impairment in the level of consciousness that interferes with the performance or interpretation of protocol specified assessments
• •4. Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
• •5. Unable, as determined by the investigator, or unwilling to discontinue use of potent P-glycoprotein (P-gp) inhibitors for the first 35 days of the study
• •6. Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome P450 (CYP) 3A4/5 inducers for the first 35 days of the study
• •7. Renal compromise (serum creatinine greater than 1.5 times the age- and sex-appropriate upper limit of normal \[ULN\]) at screening before the first dose of study drug
• •8. Severe Hepatic dysfunction (serum alanine transaminase \[ALT\], aspartate transaminase \[AST\], and/or gamma-glutamyltransferase \[GGT\] ALL greater than 2.5 times the age- and sex-appropriate ULN) or hepatic impairment (detectable ascites, serum bilirubin greater than 2 mg/dL, serum albumin less than 3.5 g/dL, and prothrombin time prolonged by more than 6 seconds above the ULN for the local laboratory in the absence of anticoagulant therapy) at screening before the first dose of study drug
• •9. Concomitant spinal cord injury or abnormality as determined by routine imaging:
• •1. Conclusive radiological evidence of complete spinal cord transection
• •2. Multiple injuries to the neurological spinal cord at different levels
• •10. History of symptomatic cervical spinal stenosis with myelopathy as a factor confounding participant assessment
• •11. Unlikely to be available for follow-up as specified in the protocol
• •12. Participated in a previous clinical study and received an investigational product within 30 days of screening
• •13. Previous exposure to SUN13837
• •14. Allergy to SUN13837 or any of its excipients
• •15. Any other issue which, in the opinion of the investigator, made the participant unsuitable for study participation.