This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.
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
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