NCT06817577 NG004 in Spinal Cord Injury Patients
| NCT ID | NCT06817577 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | NovaGo Therapeutics AG |
| Condition | Acute Spinal Cord Injury (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2024-12-18 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Director of Clinical Research
STUDY DIRECTOR
NovaGo Therapeutics AG
Frequently Asked Questions
Who can join the NCT06817577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Spinal Cord Injury (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06817577 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06817577 currently recruiting?
Yes, NCT06817577 is actively recruiting participants. Contact the research team at clinical@novagotx.com for enrollment information.
Where is the NCT06817577 trial being conducted?
This trial is being conducted at Bayreuth, Germany, Halle, Germany, Heidelberg, Germany, Murnau am Staffelsee, Germany and 2 additional locations.
Who is sponsoring the NCT06817577 clinical trial?
NCT06817577 is sponsored by NovaGo Therapeutics AG. The principal investigator is Director of Clinical Research at NovaGo Therapeutics AG. The trial plans to enroll 21 participants.