Inclusion Criteria:
- Adults (18-65 years of age, inclusive)
- Presents to a participating enrollment site and is able to receive first dose within
24 hours of non-penetrating head injury warranting clinical evaluation with a
non-contrast head CT based on American College of Emergency Physicians
(ACEP) Centers for Disease Control and Prevention (CDC) clinical policy for
TBI imaging. - Closest, prior to Randomization Glasgow Coma Scale (GCS) score of 9 to 15
- Acute trauma-related neuroimaging abnormality (subarachnoid hemorrhage,
contusion, subdural hematoma, petechial hemorrhage, intraventricular
hemorrhage) on cranial CT (CT+) - Initial Glial Fibrillary Acidic Protein (GFAP) blood level >100 pg/ml ≤ 15,000
pg/ml determined using a for Research Use Only (RUO) assay(s) or an
Investigation Use Only (IUO) assay(s) - Persons of childbearing potential (i.e., those not post-menopausal or surgically
sterile) may participate provided that they are using adequate birth control
methods for the duration of investigational product administration (see manual
of procedures for adequate birth control methods) - Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no
contraindications - Participants or legally authorized representative (LAR) willing and able
to provide informed consent - Participants or legally authorized representative able to read, speak, and
understand English or Spanish (participating site dependent, where
available) including the informed consent form(ICF)
10.Willingness and ability to comply with all study procedures, treatment, and
follow-up
Exclusion Criteria:
- Isolated epidural hematoma
- Pre-existing conditions including disabling developmental, neurologic,
psychiatric, medical disorder that continues to produce functional disability up
to the time of injury; or imminent death based on clinical judgement - Current enrollment in another interventional study
- Currently pregnant or currently breastfeeding or planning to become pregnant
in the next 6 months - Current incarceration or in custody
- Currently prescribed one of the investigational products (or other drugs in
the same class) prior to injury; or contra-indicated or as listed in the
appendices - Hypersensitivity or intolerance to the investigational products or
investigational products respective classes - Renal dysfunction (Creatinine Clearance (CrCl) or Estimated Glomerular
Filtration Rate (eGFR)<60 mL/minute/1.73 m2) - Acute liver disease or hepatic dysfunction (ALT/AST >3 times upper limit of
normal lab value)
10.Hemodynamic instability, per participating site physician investigator clinical
judgement
11.Inability to swallow investigational product capsule
12.Unable or unwilling to consume animal byproducts, has a gelatin allergy,
and/or religious beliefs that do not permit consuming gelatin
13.Intolerance to small amounts of lactose (less than ½ teaspoonful) daily
14.Low likelihood of follow up or study compliance or any other reason, in the
opinion of the participating site investigator, the participant should not
participate in the study