A first-in-human (FIH) clinical trial to investigate the human monoclonal antibody NG004, administrated intrathecally in acute spinal cord injury (SCI) patients

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514303-34-00

Acronym

NG004-SCI-001

Enrollment

Registered

2024-11-14

Start date

2024-12-18

Completion date

Unknown

Last updated

2025-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Incomplete Cervical Spinal Cord Injury

Brief summary

Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs (SAEs), and adverse drug reactions (ADRs), Safety laboratory, electrocardiogram (ECG), vital signs, physical and neurological examination, muscle spasticity (Modified Ashworth Scale), and pain (condensed version of the EMSCI Pain Assessment Form [NePAF])

Detailed description

PK parameter in serum and NG004 concentration in cerebrospinal fluid (CSF)

Interventions

DRUGNG004_DS3.1

DRUGNG004_DS4

DRUGNG004_DS1

DRUGNG004_DS2.1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs (SAEs), and adverse drug reactions (ADRs), Safety laboratory, electrocardiogram (ECG), vital signs, physical and neurological examination, muscle spasticity (Modified Ashworth Scale), and pain (condensed version of the EMSCI Pain Assessment Form [NePAF])	—

Secondary

Measure	Time frame
PK parameter in serum and NG004 concentration in cerebrospinal fluid (CSF)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026