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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
repeated intrathecal injections of NG004
Klinik für Querschnittgelähmte, Klinikum Bayreuth
Bayreuth, Germany
RECRUITINGZentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
Halle, Germany
RECRUITINGKlinik für Paraplegiologie, Universitätsklinikum Heidelberg
Heidelberg, Germany
RECRUITINGZentrum für Rückenmarksverletzte, Unfallklinik Murnau
Murnau am Staffelsee, Germany
RECRUITINGSwiss Paraplegic Centre
Nottwil, Switzerland
RECRUITINGUniversitätsklinik Balgrist
Zurich, Switzerland
RECRUITINGType, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Time frame: From treatment start up to 6 months
Maximum Plasma Concentration [Cmax] in serum
Time frame: After first and last intrathecal injection, measured at pre-dose and 1, 3, 6, 24, 48 hours post-dose.
Half-life in serum [T1/2]
Time frame: After last intrathecal injection up to 6 months
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