NCT07840196招募中1 期
A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Human Monoclonal Antibody NG004 in Acute, Incomplete Cervical Spinal Cord Injury (SCI) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
研究概览
简要总结
This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI. The trial will evaluate the safety and tolerability, PK, and effects on motor function and daily life functioning of NG004 compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) B, C and D at Screening
- •4-28 days post-injury and no earlier than 4 days after spinal surgery
- •No required mechanical ventilation or patients that do not completely depend on mechanical ventilation
- •Hemodynamically and clinical stable patient according to the acute SCI condition at baseline
排除标准
- •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
- •History of or an episode of multiple sclerosis or Guillain-Barre syndrome
- •History of recent meningitis or meningoencephalitis
- •History of refractory epilepsy
- •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 within the last 6 months before Screening
- •Pregnant or nursing women
- •History of a life-threatening allergic or immune-mediated reaction
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
NG004
Experimental
干预措施: NG004 (Drug)
结局指标
主要结局
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
时间窗: From treatment start up to 6 months
次要结局
- NG004 concentration in serum and CSF(From treatment start up to 6 months)
- Effect on neurological recovery according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol as change in ISNCSCI upper extremities motor score (UEMS) and Integrated Neurological Change Score(Baseline to 6 months)
- Effect on daily life functioning as Spinal Cord Independence Measure (SCIM-III)(Month 6)
研究者
研究点 (10)
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