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

21 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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening
days post-injury
No required mechanical ventilation or patients that not completely depend on mechanical ventilation
Hemodynamically and clinical stable patient according to the acute SCI condition at baseline

Exclusion Criteria16

Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
Multiple levels of clinically relevant spinal cord lesions
Major brachial or lumbar plexus damage/trauma
Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function
Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis
History of refractory epilepsy
History of or current autoimmune disease
Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
Presence of any unstable medical or psychiatric condition
Drug dependence any time during the 6 month's preceding trial entry
Pregnant or nursing women
History of a life-threatening allergic or immune mediated reaction
Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
Patients who are unconscious