AZD7325 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase 1 clinical trials evaluate AZD7325, primarily focusing on safety, pharmacokinetics, pharmacodynamics, and ADME properties in healthy subjects. Sponsored by AstraZeneca alongside academic institutions such as University College London, these studies encompass single ascending dose responses, biomarker activity, and drug interaction assessments, including co-administration with oral contraceptives. Trial recruitment statuses across the portfolio vary, encompassing completed studies as well as those that were suspended or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02530580	Completed	Healthy	University College London	2016-02	Phase 1
NCT02135198	Completed	Healthy	University College London	2014-09	Phase 1
NCT00940641	Suspended	Absorption\|Distribution\|Metabolism\|Excretion	AstraZeneca	2009-08	Phase 1
NCT00945425	Terminated	Healthy	AstraZeneca	2009-07	Phase 1
NCT00901290	Suspended	Pharmacokinetics	AstraZeneca	2009-05	Phase 1
NCT00769899	Completed	Healthy Volunteer	AstraZeneca	2008-10	Phase 1

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

Check the AZD7325 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD7325 functions as a potent, orally active partial positive allosteric modulator selective for GABAA α2 and α3 receptor subtypes, binding with nanomolar affinity to enhance GABA-mediated inhibitory chloride conductance. This selective potentiation of central inhibitory signaling underlies its early-stage clinical evaluation for safety, pharmacokinetics, and biomarker responsiveness in healthy volunteers.

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>).