NG004 in Spinal Cord Injury Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NG004

Group Type EXPERIMENTAL

NG004

Intervention Type DRUG

repeated intrathecal injections of NG004

Interventions

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NG004

repeated intrathecal injections of NG004

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No