First Human Trial of NG004 Antibody Delivered Into the Spine for Treating Acute Cervical Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of NG004, a human monoclonal antibody administered intrathecally, in patients with acute incomplete cervical spinal cord injury SCI. This first-in-human, multicenter, open-label trial aims to determine the maximum tolerated dose of NG004 through multiple ascending doses. The study focuses on individuals with acute cervical SCI classified as ASIA impairment scale C-D, within 4 to 28 days after injury. Participants will receive repeated intrathecal injections of NG004 across four different dose regimens. The trial does not include a placebo group and involves sequential dosing to assess safety and drug behavior in the body. Treatment monitoring will continue up to 6 months after the last injection to measure drug levels and half-life. Throughout the study, participants will be closely observed for adverse events, serious adverse events, and reactions related to NG004 starting from treatment initiation up to 6 months. Blood samples will be taken at specific times after injections to analyze drug concentration and how long it stays in the bloodstream. The trial will include patients aged 18 to 70 years who are hemodynamically stable and do not require full mechanical ventilation. The total study duration for each participant extends through the treatment and follow-up periods.

NG004 in Spinal Cord Injury Patients