Clinical Trials

A combined Phase 1 and Phase 2 clinical trial is currently investigating post-injury therapeutic protocols, specifically exercise and rehabilitation strategies, to improve functional recovery outcomes in patients affected by traumatic brain injury. Sponsored by academic and specialized clinical institutes, including the Centre for Neuro Skills and the University of Pittsburgh, the study is currently listed as enrolling by invitation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05786729 Enrolling by invitation
Traumatic Brain Injury
Centre for Neuro Skills|University of Pittsburgh
 2022-01-18 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the A-779 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

A-779 selectively binds to Angiotensin-(1-7) receptors with an IC50 of 0.3 nM, blocking Mas receptor-mediated downstream signaling pathways without significant binding affinity for AT1 or AT2 receptors. By suppressing these cellular signaling events, A-779 modulates vascular and neuroinflammatory responses, providing mechanistic relevance for therapeutic research in traumatic brain injury.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.