NG004 in Spinal Cord Injury Patients

Официальное название

A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients

Обзор

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.

Вмешательства

• Препарат NG004
  repeated intrathecal injections of NG004

Первичные конечные точки

• Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions [Срок оценки: From treatment start up to 6 months]

Вторичные конечные точки (2)

• Maximum Plasma Concentration [Cmax] in serum [Срок оценки: After first and last intrathecal injection, measured at pre-dose and 1, 3, 6, 24, 48 hours post-dose.]
• Half-life in serum [T1/2] [Срок оценки: After last intrathecal injection up to 6 months]

Критерии участия

Критерии включения

• 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
• 4-28 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 4 центра

• Klinik für Querschnittgelähmte, Klinikum Bayreuth — Bayreuth
• Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost — Halle
• Klinik für Paraplegiologie, Universitätsklinikum Heidelberg — Heidelberg
• Zentrum für Rückenmarksverletzte, Unfallklinik Murnau — Murnau am Staffelsee

Швейцария · 2 центра

• Swiss Paraplegic Centre — Nottwil
• Universitätsklinik Balgrist — Zurich

Идентификаторы

NCT: NCT06817577 · NG004-SCI-001 · 2024-514303-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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