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RECRUITING
NCT06817577
PHASE1

NG004 in Spinal Cord Injury Patients

Sponsor: NovaGo Therapeutics AG

View on ClinicalTrials.gov

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

Interventions

DRUG

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