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
Single group
NG004
Drugrepeated intrathecal injections of NG004
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Maximum Plasma Concentration [Cmax] in serum
Half-life in serum [T1/2]
Effect on motor function as Change from Baseline in ISNCSCI upper extremities motor score (UEMS), according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery.
Effect on daily life functioning according to change in Version III of the Spinal Cord Independence Measure (SCIM-III)
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.
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