Traumatic Brain InjuryPhase 1/2ANGel TNCT06282965
Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury
A Phase 1/2 study testing Angiotensin (1-7) and Sterile saline in people with Traumatic Brain Injury, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Angiotensin (1-7) and Sterile saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 external force.
- Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan 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 defined as 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.
Who cannot join
- Time of injury cannot be determined.
- Neurosurgery within the last 30 days.
- History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.
- Contraindication to having an MRI.
- Pregnant or lactating female.
- Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug.
- Participation in another clinical study involving investigational product within 30 days prior to study enrollment.
- If in the opinion of the investigator, candidate is unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Clinical Research Coordinator, (520) 237-6845, traumaresearch@arizona.edu
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury (TBI)
The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).
The main questions this trial aims to answer are:
Read more
- Is Angiotensin (1-7) safe?
- Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?
Participants will:
- Complete 21 days of study treatment consisting of a once-daily injection.
- Provide blood samples.
- Undergo two magnetic resonance imaging (MRI) scans of the brain.
- Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.
Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- Angiotensin (1-7), Sterile saline
- Keywords
- renin angiotensin system, cognition
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin (1-7)Drug
Also called Angiotensin I/II (1-7) acetate
The drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight.
Sterile salineDrug
Also called Sterile sodium chloride
Sterile solution of 0.9% NaCl in water.
| Study group | Role | What they receive |
|---|---|---|
| Ang 1-7 100 mcg/kg/day | Experimental | Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 100 micrograms per kilogram per day for 21 days. Receives: Drug: Angiotensin (1-7) |
| Ang 1-7 200 mcg/kg/day | Experimental | Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 200 micrograms per kilogram per day for 21 days. Receives: Drug: Angiotensin (1-7) |
| Placebo | Placebo comparator | Sterile saline (NaCl) will be delivered as a subcutaneous injection for 21 days. Receives: Drug: Sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
The number of participants with adverse events in each group will be compared in order to determine whether Angiotensin (1-7) is significantly associated with the occurrence of adverse events.
Measured: At 21 days
Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment consisting of eleven tasks. It is used to assess cognitive function. Errors in each task are summed for a total score ranging from 0 to 70. Higher scores represent greater cognitive dysfunction, with a score of 0 representing the least impairment and a score of 70 representing the greatest impairment.
Measured: 90 days
Secondary outcomes (8)
Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA)
Difference in performance for the treatment groups compared to controls on the Montreal Cognitive Assessment (MoCA). The range of possible scores is 0-30, with scores of 26 and above being considered normal.
Measured: 90 days
Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Differences between the treatment groups and controls on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), a 23-item inventory to assess daily functioning by asking about the participant's performance of multiple activities in the past four weeks. Scores range from 0 to 78, with 0 indicating the greatest disability.
Measured: 90 days
Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau)
Change in phosphorylated tau (p-tau), a biomarker which can predict cognitive decline, cognitive impairment, and dementia.
Measured: Enrollment to 21 days
Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days
Change in phosphorylated tau (p-tau), a biomarker which can predict cognitive decline, cognitive impairment, and dementia.
Measured: Enrollment to 90 days
Effects of Angiotensin (1-7) on brain white matter integrity
Assessment of difference in white matter integrity calculated from MR images.
Measured: MRI baseline to 90 days
Effects of Angiotensin (1-7) on length of hospital stay
Length of stay will be calculated as the difference between the admission and discharge dates.
Measured: Admission to discharge, average of 5 days
Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM)
The Confusion Assessment Method (CAM) is used to diagnose delirium using an algorithm based on the following features:
- Acute onset and fluctuating course.
- Inattention.
- Disorganized thinking.
- Altered level of consciousness.
Measured: Admission to discharge, average of 5 days
Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a brief questionnaire used to assess the severity of symptoms of depression. The range of possible scores is 0-27, with a higher score indicating greater depression severity.
Measured: Enrollment to 21 days, enrollment to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 May 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Magnotti Louis, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282965
- Sponsor's protocol ID
- AngT-001
- Acronym
- ANGel T
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wang KK, Yang Z, Zhu T, Shi Y, Rubenstein R, Tyndall JA, Manley GT. An update on diagnostic and prognostic biomarkers for traumatic brain injury. Expert Rev Mol Diagn. 2018 Feb;18(2):165-180. doi: 10.1080/14737159.2018.1428089. Epub 2018 Jan 23.
PubMed 29338452Khellaf A, Khan DZ, Helmy A. Recent advances in traumatic brain injury. J Neurol. 2019 Nov;266(11):2878-2889. doi: 10.1007/s00415-019-09541-4. Epub 2019 Sep 28.
PubMed 31563989McGinn MJ, Povlishock JT. Pathophysiology of Traumatic Brain Injury. Neurosurg Clin N Am. 2016 Oct;27(4):397-407. doi: 10.1016/j.nec.2016.06.002. Epub 2016 Aug 10.
PubMed 27637392Povlishock JT. The classification of traumatic brain injury (TBI) for targeted therapies. J Neurotrauma. 2008 Jul;25(7):717-8. doi: 10.1089/neu.2008.9964. No abstract available.
PubMed 18627251Kelley BJ, Lifshitz J, Povlishock JT. Neuroinflammatory responses after experimental diffuse traumatic brain injury. J Neuropathol Exp Neurol. 2007 Nov;66(11):989-1001. doi: 10.1097/NEN.0b013e3181588245.
PubMed 17984681Hellmich HL, Capra B, Eidson K, Garcia J, Kennedy D, Uchida T, Parsley M, Cowart J, DeWitt DS, Prough DS. Dose-dependent neuronal injury after traumatic brain injury. Brain Res. 2005 May 24;1044(2):144-54. doi: 10.1016/j.brainres.2005.02.054. Epub 2005 Apr 13.
PubMed 15885213Woodcock T, Morganti-Kossmann MC. The role of markers of inflammation in traumatic brain injury. Front Neurol. 2013 Mar 4;4:18. doi: 10.3389/fneur.2013.00018. eCollection 2013.
PubMed 23459929Israelsson C, Kylberg A, Bengtsson H, Hillered L, Ebendal T. Interacting chemokine signals regulate dendritic cells in acute brain injury. PLoS One. 2014 Aug 25;9(8):e104754. doi: 10.1371/journal.pone.0104754. eCollection 2014.
PubMed 25153123Halliwell B. Role of free radicals in the neurodegenerative diseases: therapeutic implications for antioxidant treatment. Drugs Aging. 2001;18(9):685-716. doi: 10.2165/00002512-200118090-00004.
PubMed 11599635Rudolph JL, Ramlawi B, Kuchel GA, McElhaney JE, Xie D, Sellke FW, Khabbaz K, Levkoff SE, Marcantonio ER. Chemokines are associated with delirium after cardiac surgery. J Gerontol A Biol Sci Med Sci. 2008 Feb;63(2):184-9. doi: 10.1093/gerona/63.2.184.
PubMed 18314455Ramlawi B, Rudolph JL, Mieno S, Feng J, Boodhwani M, Khabbaz K, Levkoff SE, Marcantonio ER, Bianchi C, Sellke FW. C-Reactive protein and inflammatory response associated to neurocognitive decline following cardiac surgery. Surgery. 2006 Aug;140(2):221-6. doi: 10.1016/j.surg.2006.03.007.
PubMed 16904973Raizada MK, Ferreira AJ. ACE2: a new target for cardiovascular disease therapeutics. J Cardiovasc Pharmacol. 2007 Aug;50(2):112-9. doi: 10.1097/FJC.0b013e3180986219.
PubMed 17703127Vickers C, Hales P, Kaushik V, Dick L, Gavin J, Tang J, Godbout K, Parsons T, Baronas E, Hsieh F, Acton S, Patane M, Nichols A, Tummino P. Hydrolysis of biological peptides by human angiotensin-converting enzyme-related carboxypeptidase. J Biol Chem. 2002 Apr 26;277(17):14838-43. doi: 10.1074/jbc.M200581200. Epub 2002 Jan 28.
PubMed 11815627Massaad CA, Klann E. Reactive oxygen species in the regulation of synaptic plasticity and memory. Antioxid Redox Signal. 2011 May 15;14(10):2013-54. doi: 10.1089/ars.2010.3208. Epub 2010 Oct 28.
PubMed 20649473Santos RA, Ferreira AJ, Verano-Braga T, Bader M. Angiotensin-converting enzyme 2, angiotensin-(1-7) and Mas: new players of the renin-angiotensin system. J Endocrinol. 2013 Jan 18;216(2):R1-R17. doi: 10.1530/JOE-12-0341. Print 2013 Feb.
PubMed 23092879
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT06282965
- Acronym / sponsor ID
- ANGel T / AngT-001
- Conditions
- Traumatic Brain Injury
- Keywords
- renin angiotensin system, cognition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 28 May 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).
The main questions this trial aims to answer are:
- Is Angiotensin (1-7) safe?
- Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?
Participants will:
- Complete 21 days of study treatment consisting of a once-daily injection.
- Provide blood samples.
- Undergo two magnetic resonance imaging (MRI) scans of the brain.
- Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.
Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ang 1-7 100 mcg/kg/day | Experimental | Drug: Angiotensin (1-7)Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 100 micrograms per kilogram per day for 21 days. |
| Ang 1-7 200 mcg/kg/day | Experimental | Drug: Angiotensin (1-7)Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 200 micrograms per kilogram per day for 21 days. |
| Placebo | Placebo comparator | Drug: Sterile salineSterile saline (NaCl) will be delivered as a subcutaneous injection for 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 external force.
- Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan 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 defined as 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.
Key exclusion criteria (8 listed)
- Time of injury cannot be determined.
- Neurosurgery within the last 30 days.
- History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.
- Contraindication to having an MRI.
- Pregnant or lactating female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin (1-7)Also: Angiotensin I/II (1-7) acetateThe drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight. | Drug | Ang 1-7 100 mcg/kg/day, Ang 1-7 200 mcg/kg/day |
| Sterile salineAlso: Sterile sodium chlorideSterile solution of 0.9% NaCl in water. | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: At 21 days
The number of participants with adverse events in each group will be compared in order to determine whether Angiotensin (1-7) is significantly associated with the occurrence of adverse events.
Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time frame: 90 days
The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment consisting of eleven tasks. It is used to assess cognitive function. Errors in each task are summed for a total score ranging from 0 to 70. Higher scores represent greater cognitive dysfunction, with a score of 0 representing the least impairment and a score of 70 representing the greatest impairment.
8 secondary outcomes
Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: 90 days
Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: 90 days
Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau)
Time frame: Enrollment to 21 days
Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days
Time frame: Enrollment to 90 days
Effects of Angiotensin (1-7) on brain white matter integrity
Time frame: MRI baseline to 90 days
Effects of Angiotensin (1-7) on length of hospital stay
Time frame: Admission to discharge, average of 5 days
Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM)
Time frame: Admission to discharge, average of 5 days
Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Enrollment to 21 days, enrollment to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 29338452Wang KK, Yang Z, Zhu T, Shi Y, Rubenstein R, Tyndall JA, Manley GT. An update on diagnostic and prognostic biomarkers for traumatic brain injury. Expert Rev Mol Diagn. 2018 Feb;18(2):165-180. doi: 10.1080/14737159.2018.1428089. Epub 2018 Jan 23.
- Background: PubMed 31563989Khellaf A, Khan DZ, Helmy A. Recent advances in traumatic brain injury. J Neurol. 2019 Nov;266(11):2878-2889. doi: 10.1007/s00415-019-09541-4. Epub 2019 Sep 28.
- Background: PubMed 27637392McGinn MJ, Povlishock JT. Pathophysiology of Traumatic Brain Injury. Neurosurg Clin N Am. 2016 Oct;27(4):397-407. doi: 10.1016/j.nec.2016.06.002. Epub 2016 Aug 10.
- Background: PubMed 18627251Povlishock JT. The classification of traumatic brain injury (TBI) for targeted therapies. J Neurotrauma. 2008 Jul;25(7):717-8. doi: 10.1089/neu.2008.9964. No abstract available.
- Background: PubMed 17984681Kelley BJ, Lifshitz J, Povlishock JT. Neuroinflammatory responses after experimental diffuse traumatic brain injury. J Neuropathol Exp Neurol. 2007 Nov;66(11):989-1001. doi: 10.1097/NEN.0b013e3181588245.
- Background: PubMed 15885213Hellmich HL, Capra B, Eidson K, Garcia J, Kennedy D, Uchida T, Parsley M, Cowart J, DeWitt DS, Prough DS. Dose-dependent neuronal injury after traumatic brain injury. Brain Res. 2005 May 24;1044(2):144-54. doi: 10.1016/j.brainres.2005.02.054. Epub 2005 Apr 13.
- Background: PubMed 23459929Woodcock T, Morganti-Kossmann MC. The role of markers of inflammation in traumatic brain injury. Front Neurol. 2013 Mar 4;4:18. doi: 10.3389/fneur.2013.00018. eCollection 2013.
- Background: PubMed 25153123Israelsson C, Kylberg A, Bengtsson H, Hillered L, Ebendal T. Interacting chemokine signals regulate dendritic cells in acute brain injury. PLoS One. 2014 Aug 25;9(8):e104754. doi: 10.1371/journal.pone.0104754. eCollection 2014.
- Background: PubMed 11599635Halliwell B. Role of free radicals in the neurodegenerative diseases: therapeutic implications for antioxidant treatment. Drugs Aging. 2001;18(9):685-716. doi: 10.2165/00002512-200118090-00004.
- Background: PubMed 18314455Rudolph JL, Ramlawi B, Kuchel GA, McElhaney JE, Xie D, Sellke FW, Khabbaz K, Levkoff SE, Marcantonio ER. Chemokines are associated with delirium after cardiac surgery. J Gerontol A Biol Sci Med Sci. 2008 Feb;63(2):184-9. doi: 10.1093/gerona/63.2.184.
- Background: PubMed 16904973Ramlawi B, Rudolph JL, Mieno S, Feng J, Boodhwani M, Khabbaz K, Levkoff SE, Marcantonio ER, Bianchi C, Sellke FW. C-Reactive protein and inflammatory response associated to neurocognitive decline following cardiac surgery. Surgery. 2006 Aug;140(2):221-6. doi: 10.1016/j.surg.2006.03.007.
- Background: PubMed 17703127Raizada MK, Ferreira AJ. ACE2: a new target for cardiovascular disease therapeutics. J Cardiovasc Pharmacol. 2007 Aug;50(2):112-9. doi: 10.1097/FJC.0b013e3180986219.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnotti Louis, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Angiotensin (1-7) and Sterile saline in people with Traumatic Brain Injury, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator ((520) 237-6845, traumaresearch@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: At 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06282965, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.