Apramycin Sulfate Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Apramycin sulfate is currently evaluated in a clinical trial targeting bacterial infections. Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), this actively recruiting Phase 1 open-label study investigates the lung pharmacokinetics and safety of a single intravenous dose in healthy adult volunteers. This early-phase evaluation aims to establish crucial human pharmacokinetic and tolerability parameters to inform future clinical strategies against bacterial infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05590728	Recruiting	Bacterial Infection	National Institute of Allergy and Infectious Diseases (NIAID)	2023-06-16	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apramycin sulfate selectively binds to the deep groove of bacterial ribosomal RNA, thereby disrupting translation fidelity and blocking protein synthesis. This inhibition of critical protein production leads to bacterial growth arrest and cell death, establishing the pharmacological basis for its clinical development against bacterial infection.

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>).