Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
Condition: Acute Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Intervention: SUN13837 injection; Placebo
Intervention description: SUN13837 injection, injection 1 x daily for 28 doses; Matching placebo, volume equivalent to injection 1 x daily for 28 doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ASCI; SUN13837; Acute traumatic cervical spinal cord injury

Summary:

      The purpose of this research study is to gather scientific information about the
      effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive
      substance) in participants with acute spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Acute traumatic injury to the cervical neurological spinal cord as follows:

               1. American Spinal Injury Association Impairment Scale A (AIS A) with a level of
                  injury at either cervical level C4, C5, C6, C7 (for C4, the participant must have
                  at least 1 point of motor activity within the zone of partial preservation (ZPP)
                  inclusive of C5 to thoracic level 1 [T1]). In addition, the AIS A participant may
                  be included if ALL of the following are present 1) the most caudal intact sensory
                  segment (both pinprick and light touch) is C3, 2) at least one side (right or
                  left) has both intact pinprick and light touch sensation in the C4 dermatome, AND
                  3) at least 1 point of motor activity within the ZPP inclusive of C5 to T1

               2. American Spinal Injury Association Impairment Scale B or C (AIS B or C) with a
                  neurological level of injury at either C3, C4, C5, C6, C7, or C8 AND a total LEMS
                  of 5 or fewer motor points

          2. Closed single traumatic spinal cord injury occurring within 12 hours of first dosing

          3. Male or female cervical AIS A participants ≥ 16 to ≤ 80 years and male or female
             cervical AIS B or C participants ≥16 to ≤70 years

          4. Females of childbearing potential and males must agree to maintain adequate
             contraception for the first 35 days of the study

        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.