Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by AstraZeneca evaluated the therapeutic potential and pharmacological profile of AZD6280 in healthy volunteers and patients with anxiety. These early-phase investigations utilized positron emission tomography to evaluate central GABAA receptor occupancy and assessed pharmacokinetic interactions with CYP3A4 substrates. Ultimately, these studies established the preliminary safety, tolerability, pharmacokinetics, and target engagement of AZD6280 in human subjects.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00824057 Completed
Healthy
AstraZeneca
 2009-01 Phase 1
NCT00750802 Completed
Healthy Volunteer
AstraZeneca
 2008-09 Phase 1
NCT00720421 Completed
Healthy Volunteer
AstraZeneca
 2008-06 Phase 1
NCT00681317 Completed
Healthy Volunteer
AstraZeneca
 2008-03 Phase 1
NCT00681746 Completed
Anxiety
AstraZeneca
 2008-02 Phase 1

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

Check the AZD6280 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD6280 acts as a selective modulator of GABAA receptors containing α2 and α3 subunits, enhancing GABA-induced chloride ion influx to hyperpolarize postsynaptic membranes. This targeted enhancement of inhibitory neurotransmission dampens central nervous system hyperexcitability, providing the biological rationale for suppressing clinical anxiety symptoms.

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.