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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT06282965
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Angiotensin (1-7) — DRUG
    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 saline — DRUG
    Sterile solution of 0.9% NaCl in water.

Study Details

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.

Key Dates

Start date
May 28, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ang 1-7 100 mcg/kg/day
    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.
  • Experimental: Ang 1-7 200 mcg/kg/day
    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 Comparator: Placebo
    Sterile saline (NaCl) will be delivered as a subcutaneous injection for 21 days.

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: At 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Clinical Research Coordinator
[email protected]
520-237-6845

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By research site
University of Arizona· Tucson, AZ

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