This is the first-time-in-humans study of an experimental drug called NG004 for people with recent spinal cord injuries in the neck area. The study will test whether NG004 is safe and well-tolerated, and will measure how the body processes the drug at different dose levels.
Key Objective:This trial is testing whether NG004 can be safely given to spinal cord injury patients and may help restore some function after acute cervical spinal cord injury.
Who to Consider:People with a recent incomplete cervical spinal cord injury who are interested in potentially participating in an early-stage experimental treatment study should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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), gastrointestina