AFN-1252 Clinical Trials

Size	Price	Qty
5mg	USD 190

Clinical Trials

Several clinical trials sponsored by Debiopharm International SA have been completed to evaluate the small-molecule therapeutic AFN-1252 in Phase 1 studies. The research targeted both healthy participants and patients diagnosed with infectious bone diseases. Specifically, these trials investigated pharmacokinetic drug-drug interactions involving itraconazole co-administration in healthy volunteers and assessed bone tissue penetration following repeated oral administration in individuals with infectious bone diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03209648	Completed	Healthy Participants	Debiopharm International SA	2017-06-14	Phase 1
NCT02726438	Completed	Bone Diseases Infectious	Debiopharm International SA	2016-04	Phase 1

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

Check the AFN-1252 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AFN-1252 selectively binds to and inhibits bacterial enoyl-acyl carrier protein reductase (FabI), thereby blocking essential fatty acid biosynthesis necessary for cell membrane construction and survival. This targeted metabolic disruption halts bacterial cell growth across clinical isolates of Staphylococcus aureus and Staphylococcus epidermidis, supporting its clinical application in addressing staphylococcal infections such as infectious bone diseases.

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>).