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NG004 in Spinal Cord Injury Patients
Sponsor: NovaGo Therapeutics AG
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.
Official title: A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2024-12-18
Completion Date
2026-09
Last Updated
2025-02-10
Healthy Volunteers
No
Conditions
Interventions
NG004
repeated intrathecal injections of NG004
Locations (6)
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
Murnau am Staffelsee, Germany
Swiss Paraplegic Centre
Nottwil, Switzerland
Universitätsklinik Balgrist
Zurich, Switzerland