Cosmos Trial: Cerebroprotection Of AST-004 in Mild Complicated Traumatic Brain Injuries

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Astrocyte Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-06-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

This study will evaluate the safety and efficacy of AST-004 as a cerebroprotective treatment for patients with complicated mild TBI.

Conditions and MedDRA coding

Traumatic brain injury

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult - age 18-70 years
2. Complicated-mild TBI - defined as Glasgow Coma Scale (GCS) 13-15 with traumatic lesions on head CT scan obtained in the ED.
3. Subject has minor or no extracranial injuries
4. Injuries do not require admission to an intensive care unit
5. Able to initiate treatment with AST-004 within 12h from injury.
6. Male and female participants of childbearing potential must agree to use an effective method of birth control or abstain from sexual relations that could result in pregnancy for 14 days after receiving treatment with AST-004.
7. Informed Consent obtained from patient or a legally authorized representative (LAR).

Exclusion criteria 15

1. Current enrollment in another interventional, therapeutic clinical study that may affect the results of this study (an observational study is acceptable)
2. Time of injury cannot be determined
3. Females breastfeeding/lactating or with a positive pregnancy test.
4. Patients who require acute surgical and/or neurosurgical interventions or sedation requiring endotracheal intubation
5. Participant has a pre-injury cognitive impairment that prevents them from completing clinical assessments as required
6. Known end-stage renal disease or receiving dialysis of any form
7. Venipuncture not feasible
8. Known history of seizures including febrile seizures or a first degree relative with epilepsy
9. Subject has a major neurological (e.g., a history of a brain tumor, neurosurgery, stroke or transient ischemic attack (TIA), etc.) or psychiatric/behavioral disorder co-morbidity
10. Administration of, or plans for, a blood transfusion during study participation
11. Current abuse of any drugs that are illegal under the Dutch country law.
12. Administration within the past 90 d of darolutamide, eltrombopag, febuxostat, fostamatinib, teriflunomide or need to administer these medications during the first 48 hours post-dose
13. Subject is under the influence of alcohol, any stimulant, nitrates, mind alternating illicit drug or of alternative medications or supplements with stimulant properties (e.g., ephedra) or vasodilatory properties (e.g., nitrate containing supplements) and in the opinion of the Investigator alters ability to complete study assessments and/or study results
14. Prior TBI within the previous 6 months.
15. Non-Dutch or English speaking ability or illiteracy that would interfere with understanding follow-up questionnaires

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Primary safety endpoint: Safety of different doses of AST-004 as determined by the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) occurring through Day 7.
2. Primary pharmacodynamic endpoint: Physiologic effect of AST-004 as determined by the change in plasma GFAP from baseline/pre-dose through the dose-completion, 24 hours, Day 7, Day 14 and Day 30 timepoints. The effect at 24 hours will be of primary interest.

Secondary endpoints 2

1. Clinical effect of AST-004 as determined by change in Rivermead symptom scores from baseline/pre-dose through Day 14.
2. Cerebroprotective effect of AST-004 as determined by differences in neuronal integrity, membrane turnover, glial activation, and neuroinflammation, measured as changes in N-acetylaspartate, choline-containing compounds, and myo-inositol on conventional MR spectroscopy at 24 hours and Day 14, and by the difference between these timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astrocyte Pharmaceuticals Inc.

Sponsor organisation

Astrocyte Pharmaceuticals Inc.

Address

93 Shennecossett Road

City

Groton

Postcode

06340-5115

Country

United States

Scientific contact point

Organisation

Astrocyte Pharmaceuticals Inc.

Contact name

Lisa Manna

Public contact point

Organisation

Astrocyte Pharmaceuticals Inc.

Contact name

Lisa Manna

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications