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. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions — From treatment start up to 6 months
Trial sites (6)
Facility
City
Region
Status
Klinik für Querschnittgelähmte, Klinikum Bayreuth
Bayreuth
Germany
Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
Halle
Germany
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
Heidelberg
Germany
Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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