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Safety and Efficacy of AST-004 in Patients with Mild Complicated Traumatic Brain Injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have suffered a mild complicated Traumatic brain injury. The investigational medicine being tested is called AST-004, which is given by an intravenous (through a vein) infusion. A matching inactive treatment known as a placebo will be used for comparison.

The purpose is to find out whether AST-004 can protect the brain and be safe for patients with this type of injury. Participants will receive a single infusion of either the study drug or the placebo shortly after their injury, remain in the hospital for a brief observation period, and then attend a few follow‑up visits over roughly one month.

During the follow‑up, blood samples will be taken to measure a protein called GFAP that indicates brain cell damage, and a special brain scan using MR spectroscopy will be performed to examine brain chemistry. Researchers will monitor for any side effects and record changes in how patients feel and function.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry and baseline assessments
After joining the trial, baseline measurements are taken. these include a medical history review, physical examination, blood sample, brain imaging, and a symptom questionnaire called the rivermead symptom score.
The baseline blood sample is used to measure a protein called gfap, which helps evaluate brain injury.
Step 2
Randomization to treatment
Participants are randomly assigned to receive either the active drug ast-004 or a placebo that looks the same but contains no active substance.
Step 3
Administration of study drug
The assigned product is given as a single intravenous infusion. the active drug is a solution for injection containing 1210 mg of ast-004. the placebo is an identical‑appearing solution without any active ingredient.
The infusion is administered once, and the infusion period ends when the full dose has been delivered.
Step 4
Immediate post‑infusion monitoring
After the infusion, participants are observed for several hours to check for any immediate side effects or adverse events.
Step 5
Blood sample at dose completion
A blood sample is taken at the end of the infusion to measure the level of gfap after the dose.
Step 6
24‑hour follow‑up (day 1)
Approximately 24 hours after the infusion, a follow‑up visit occurs.
Blood is drawn to measure gfap, and a brain scan using mr spectroscopy is performed to assess neuronal health.
The rivermead symptom score may be repeated to track early symptom changes.
Step 7
Day 7 safety assessment
On day 7, participants return for a safety check. the visit includes a review of any adverse events that have occurred and a blood sample for gfap measurement.
Step 8
Day 14 clinical and imaging assessment
On day 14, the rivermead symptom score is recorded again to evaluate clinical effect.
Mr spectroscopy of the brain is repeated to compare neuronal markers with earlier scans.
A blood sample for gfap is collected, and safety is reassessed.
Step 9
Day 30 final safety follow‑up
The last scheduled visit occurs on day 30.
Participants undergo a final safety evaluation and a blood draw to measure gfap.

Who can join the trial?

7 criteria

You must be an adult between 18 and 70 years old.
You must have a complicated mild traumatic brain injury, which means a mild brain injury (a Glasgow Coma Scale score of 13‑15) plus visible damage on a head CT scan taken in the emergency department.
You should have minor or no injuries outside the head (no significant injuries to other parts of the body).
Your injuries must not require staying in an intensive care unit (a special hospital area for very seriously ill patients).
You need to be able to start the study medication within 12 hours after the injury occurs.
If you could become pregnant, you must agree to use an effective method of birth control or avoid sexual activity that could lead to pregnancy for 14 days after receiving the medication.
You must provide informed consent, either yourself or through a legally authorized representative (LAR) who can give permission on your behalf.

Who cannot join the trial?

15 criteria

Being enrolled right now in another interventional (testing a new treatment) and therapeutic (intended to help) clinical study that could change the results of this study (a simple observation‑only study is allowed).
Receiving, or planning to receive, a blood transfusion (getting donated blood) while taking part in this study.
Currently abusing any illegal drugs according to Dutch law.
Having taken any of the following medicines within the past 90 days, or needing to take them in the first 48 hours after the study dose: darolutamide, eltrombopag, febuxostat, fostamatinib, teriflunomide.
Being under the influence of alcohol, stimulants (substances that increase activity), nitrates, illicit drugs, or supplements that act like stimulants (e.g., ephedra) or vasodilators (substances that widen blood vessels, e.g., nitrate‑containing supplements), and the investigator believes this could affect your ability to complete study tests.
Having had another traumatic brain injury (TBI) within the past 6 months.
Not being able to speak Dutch or English, or being illiterate in a way that would prevent you from understanding follow‑up questionnaires.
When the exact time of the injury cannot be determined.
Being pregnant, breastfeeding, or having a positive pregnancy test.
Needing urgent surgical or neurosurgical (brain‑related) procedures, or requiring sedation that involves endotracheal intubation (a breathing tube placed in the windpipe).
Having a pre‑injury cognitive impairment (difficulty thinking or remembering) that would stop you from completing the study assessments.
Having known end‑stage renal disease (very severe kidney failure) or currently receiving any form of dialysis (machine‑based kidney treatment).
If a blood draw (venipuncture) is not possible.
Having a known history of seizures, including febrile seizures (seizures caused by fever), or having a first‑degree relative (parent, sibling, or child) with epilepsy (a disorder that causes repeated seizures).
Having a major neurological condition such as a history of a brain tumor, prior brain surgery, stroke, or transient ischemic attack (TIA) (a brief, temporary stroke), or a major psychiatric/behavioral disorder.

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Verified sites

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Universitair Medisch Centrum Groningen
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Groningen, The Netherlands

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Investigated drugs

AST-004 is an experimental medicine being tested to protect the brain after a mild but complicated head injury. In the study, it is given through an IV (a needle placed in a vein) as a liquid that can be injected. Researchers are watching how safe it is for patients and whether it helps reduce brain damage and improve recovery compared with not receiving the drug.

What is already known about the treatment

AST-004 - AST-004 is given as a sterile solution for injection that is delivered directly into a vein (intravenous). It is still an investigational drug, currently being studied in clinical trials and not yet approved for routine medical use. The medication is being tested to protect the brain after a mild but complicated traumatic brain injury. It works by activating protective cell signals that help keep blood flow steady and reduce inflammation, placing it in the class of neuro‑protective agents.

Investigated diseases

Traumatic brain injury - Traumatic brain injury is damage to the brain caused by a sudden blow or jolt to the head. It can result in bruising, bleeding, or swelling of brain tissue. Shortly after the injury, a person may experience headache, confusion, or loss of balance. In the following hours to days, symptoms may change as swelling increases or as the brain begins to heal. Some people notice memory problems, difficulty concentrating, or changes in mood as the injury evolves. The condition typically follows a pattern of initial impact, a period of symptom fluctuation, and gradual stabilization.