AXER-204 in Participants With Chronic Spinal Cord Injury

About this trial

This is a trial to test the safety, tolerability, and efficacy of different doses of a drug called AXER-204. The adult central nervous system maintains a set of proteins that limit growth and are bound to receptors on neurons. AXER-204 is a “decoy” or “trap” receptor that intercepts the blocking of these inhibitory proteins with the normal receptors. The presence of AXER-204 is designed to release the blockade on axon growth or axon regeneration after spinal cord injury (SCI). Animal experiments have shown that the AXER-204 human protein can remove this block and promote axonal regeneration and functional recovery after spinal cord injury. The study consists of two parts. If included in Part 1 of the trial, four groups of 6 participants will receive a single dose of AXER-204 (differing concentrations). If included in Part 2 of the trial, the participants will receive 1) repeated doses of AXER-204, or 2) repeated doses of an inactive drug (placebo control). The dose level and frequency will be dependent upon results from Part 1. The infusions are administered through a needle inserted between two vertebrae of the lower back (lumbar puncture). Final neurological examinations will be performed after 6 months.