Acute Spinal Cord Injury (SCI)Phase 1SPROUTNCT06817577
NG004 in Spinal Cord Injury Patients
A Phase 1 study testing NG004 in people with Acute Spinal Cord Injury (SCI) and Spinal Cord Diseases, run by NovaGo Therapeutics AG at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Central Nervous System Diseases
- What is being tested?
- NG004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Dec 2024to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
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
Switzerland2 sites
Swiss Paraplegic Centre
Nottwil
Universitätsklinik Balgrist
Zurich
About this study
Official title: A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients
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. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).
- Conditions
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Spinal Cord Injuries (SCI)
- Being tested
- NG004
- Keywords
- Acute spinal cord injury, Nogo-A, SPROUT, Regeneration
- Medical subject headings
- Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Spinal Cord Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG004Drug
repeated intrathecal injections of NG004
| Study group | Role | What they receive |
|---|---|---|
| NG004 | Experimental | Not described Receives: Drug: NG004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Measured: From treatment start up to 6 months
Secondary outcomes (2)
Maximum Plasma Concentration [Cmax] in serum
Measured: 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]
Measured: After last intrathecal injection up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start18 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaGo Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director of Clinical Research, Study director, NovaGo Therapeutics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817577
- Sponsor's protocol ID
- NG004-SCI-001
- Other IDs
- 2024-514303-34-00
- Acronym
- SPROUT
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients
- ClinicalTrials.gov ID
- NCT06817577
- Acronym / sponsor ID
- SPROUT / NG004-SCI-001
- Conditions
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Spinal Cord Injuries (SCI)
- Keywords
- Acute spinal cord injury, Nogo-A, SPROUT, Regeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NovaGo Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NG004 | Experimental | Drug: NG004 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NG004repeated intrathecal injections of NG004 | Drug | NG004 |
Primary outcome
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Time frame: From treatment start up to 6 months
2 secondary outcomes
Maximum Plasma Concentration [Cmax] in serum
Time frame: 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]
Time frame: After last intrathecal injection up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director of Clinical Research study director
NovaGo Therapeutics AG
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NG004 in people with Acute Spinal Cord Injury (SCI) and Spinal Cord Diseases, run by NovaGo Therapeutics AG at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions (time frame: From treatment start up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.