A first-in-human (FIH) clinical trial to investigate the human monoclonal antibody NG004, administrated intrathecally in acute spinal cord injury (SCI) patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening * 4-28 days post-injury * No required mechanical ventilation or patients that not completely depend on mechanical ventilation * Hemodynamically and clinical stable patient according to the acute SCI condition at baseline Exclusion Criteria: * Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds * Multiple levels of clinically relevant spinal cord lesions * Major brachial or lumbar plexus damage/trauma * Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function * Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy * History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis * History of refractory epilepsy * History of or current autoimmune disease * Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI * Presence of any unstable medical or psychiatric condition * Drug dependence any time during the 6 month's preceding trial entry * Pregnant or nursing women * History of a life-threatening allergic or immune mediated reaction * Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections * Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations * Patients who are unconscious