NG004 in Spinal Cord Injury Patients
NCT06817577 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-02-10
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
- Wounds and Injuries
- Acute Spinal Cord Injury (SCI)
- Spinal Cord Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Trauma, Nervous System
- Spinal Cord Injuries (SCI)
Interventions
- DRUG
-
NG004
repeated intrathecal injections of NG004
Sponsors & Collaborators
-
NovaGo Therapeutics AG
lead INDUSTRY
Principal Investigators
-
Director of Clinical Research · NovaGo Therapeutics AG
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-18
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- Germany
- Switzerland
Study Locations
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