AZD3839 Clinical Trials

Size	Price	Qty
10mg	USD 297
50mg	USD 977

Clinical Trials

Multiple clinical trials sponsored by the pharmaceutical company AstraZeneca have investigated the small-molecule inhibitor AZD3839 for the potential treatment of Alzheimer's disease. These Phase 1, randomized, placebo-controlled studies evaluated the safety, tolerability, and pharmacokinetic profiles of the compound in healthy volunteers using single ascending dose designs. All registered trials have completed recruitment, providing foundational Phase 1 human safety and pharmacodynamic data for this neurodegenerative disease program.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01348737	COMPLETED	Alzheimer's Disease; Safety; Tolerability; Blood Concentration; Healthy Volunteers	AstraZeneca	2011-06	PHASE1
NCT01348737	Completed	Alzheimer''s Disease\|Safety\|Tolerability\|Blood Concentration\|Healthy Volunteers	AstraZeneca	2011-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2012-04-06)

Check the AZD3839 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD3839 selectively binds to beta-site APP cleaving enzyme 1 (BACE1) with a Ki of 26.1 nM, blocking the proteolytic cleavage of amyloid precursor protein and thereby inhibiting the cellular production of neurotoxic amyloid-beta peptides. By reducing amyloid-beta accumulation and subsequent plaque formation in the central nervous system, this targeted enzymatic inhibition provides the therapeutic rationale evaluated in Phase 1 clinical trials for Alzheimer's disease.

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>).