Trials / Recruiting
RecruitingNCT06817577
NG004 in Spinal Cord Injury Patients
A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- NovaGo Therapeutics AG · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Spinal Cord Injury (SCI)
- Spinal Cord Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Trauma, Nervous System
- Spinal Cord Injuries (SCI)
- Wounds and Injuries
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NG004 | repeated intrathecal injections of NG004 |
Timeline
- Start date
- 2024-12-18
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2025-02-10
- Last updated
- 2025-02-10
Locations
6 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT06817577. Inclusion in this directory is not an endorsement.