RecruitingPhase 1NCT06817577

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

Sponsor

NovaGo Therapeutics AG

Enrollment

20 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Spinal Cord Diseases Wounds and Injuries Spinal Cord Injuries (SCI)Acute Spinal Cord Injury (SCI)

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. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NG004 for people with acute spinal cord injury (sci), central nervous system diseases, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.