Conditions: Acute Spinal Cord Injury
Keywords: Acute Traumatic SCI Spinal Cord Injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.

Detailed description:
To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).

Arms:
arm 1: Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. arm 2: Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.

Interventions: intervention 1: AC105 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: