Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury

Inclusion Criteria: * Written informed consent from patient's legal guardian or legal representative * 18 - 65 years of age, inclusive * Head trauma within the last 12 hours * Traumatic brain injury with Glasgow Coma Score (GCS) ≥ 5 and that requires ICP monitoring * Catheter placement for monitoring and management of increased ICP * Microdialysis probe placement in penumbra zone or ipsilateral to contusion if focal * Systolic blood pressure ≥ 100 mmHg * Females of child-bearing potential must have a negative pregnancy test Exclusion Criteria: * Penetrating head injury (e.g. missile, stab wound) * Not expected to survive more than 24 hours after admission * Concurrent, but not pre-existing, spinal cord injury * Unilateral and bilateral fixed and dilated pupil (\> 4 mm) * Cardiopulmonary resuscitation performed post injury * continuing bleeding likely to require multiple transfusions (\> 4 units red blood cells) * Coma due to a "pure" epidural hematoma (lucid interval and absence of structural brain damage on CT scan) * Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose) * Known or CT scan evidence of pre-existing major cerebral damage * Decompressive craniectomy, planned prior to randomization * Polytraumatic patients with Injury Severity Score \> 25, or rhabdomyolysis * Injuries to ascending aorta and/or carotid arteries * serum creatinine values \> 1.5 mg/dL * estimated Glomerular Filtration Rate \< 60 ml/min (MDRD-formula) * body mass index (BMI) \> 35, Body weight \> 120 kg * Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission * Known to have received an experimental drug within 4 weeks prior to current injury * Administration of \> 100 ml of contrast media containing iodine