Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury

Inclusion Criteria:

• Participant or representative willing to provide informed consent.

• Age 18 years or older at time of enrollment.

• Traumatically induced head injury resulting from insult to head from an externalforce.

• Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CTscan and report must be available.

• Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS)score on trauma presentation of 12 or less. In general: Moderate TBI will be definedas loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12.Severe TBI will be defined as loss of consciousness > 24 hours and GCS ≤ 9.

• Enrollment within 48 hours of TBI.

Exclusion Criteria:

• Time of injury cannot be determined.

• Neurosurgery within the last 30 days.

• History of neurodegenerative disease or disorder including dementia, Parkinson'sdisease, multiple sclerosis, seizure disorder, or brain tumors that would impactcognitive testing.

• Contraindication to having an MRI.

• Pregnant or lactating female.

• Female of childbearing potential or sexually active male who is not willing to usean acceptable method of birth control for the treatment period and 7 days after thelast dose of the study drug.

• Participation in another clinical study involving investigational product within 30days prior to study enrollment.

• If in the opinion of the investigator, candidate is unsuitable for participation inthe study.