R406 Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 870

Clinical Trials

Multiple clinical trials have evaluated R406, predominantly comprising completed Phase 1 studies sponsored by AstraZeneca. These trials primarily investigated the pharmacokinetics, absolute bioavailability, bioequivalence, and drug-drug interactions of the compound in healthy volunteers and special populations, including individuals with rheumatoid arthritis, renal impairment, and hepatic impairment. Overall, the clinical development landscape reflects early-phase human evaluation centered on safety, dosing parameters, and systemic disposition.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01645085	COMPLETED	Healthy Volunteers	AstraZeneca	2012-07	PHASE1
NCT01682408	COMPLETED	Pharmacokinetics	AstraZeneca	2012-09	PHASE1
NCT01725230	Completed	Rheumatoid Arthritis	AstraZeneca	2012-11	Phase 1
NCT01598571	COMPLETED	Healthy	AstraZeneca	2012-05	PHASE1
NCT01598571	Completed	Healthy	AstraZeneca	2012-05	Phase 1
NCT01387308	Completed	Healthy	AstraZeneca	2011-08	Phase 1
NCT01336218	COMPLETED	Rheumatoid Arthritis; Healthy Volunteers	AstraZeneca	2011-04	PHASE1
NCT01355354	Completed	Healthy Volunteers\|Rheumatoid Arthritis	AstraZeneca	2011-06	Phase 1
NCT01245790	COMPLETED	Rheumatoid Arthritis; Renal Impairment	AstraZeneca	2010-11	PHASE1
NCT01222455	COMPLETED	Hepatic Impairment; Healthy Volunteers; Pharmacokinetics; Amount of R406 in Blood	AstraZeneca	2010-10	PHASE1
NCT01197781	COMPLETED	Drug Drug Interactions; Healthy Volunteers	AstraZeneca	2010-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2013-03-19)

Check the R406 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

R406 selectively binds to and inhibits spleen tyrosine kinase (Syk), thereby blocking Syk-dependent receptor signaling pathways, including B-cell receptor and Fc receptor activation, which suppresses immune cell activation and induces cell apoptosis. By mitigating immune-cell-mediated inflammatory signaling and downstream gene expression, this targeted enzyme inhibition provides the primary rationale for evaluating R406 in autoimmune conditions such as rheumatoid arthritis.

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>).