Aluminium hydroxide Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple Phase 2 and Phase 3 clinical trials sponsored by industry entities, including Leti Pharma GmbH and Sinovac Biotech Co. Ltd, have evaluated formulations incorporating aluminium hydroxide as an adjuvant or therapeutic component. These studies, with recruitment statuses ranging from completed to withdrawn, focus on viral enterovirus infections as well as birch pollen-induced allergic rhinitis or rhinoconjunctivitis, with or without intermittent asthma. Overall, these investigations evaluate safety and immunomodulatory efficacy across allergy and infectious disease indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01694836	Completed	Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma\|Sensitization Against Betula Alba (Birch) Pollen	Leti Pharma GmbH	2012-09-17	Phase 3
NCT01812135	Withdrawn	Infection Viral Enterovirus	Sinovac Biotech Co. Ltd	2011-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aluminium hydroxide directly neutralizes gastric hydrochloric acid to decrease luminal hydrogen ion concentrations and forms insoluble antigen depots that trigger NLRP3 inflammasome activation in local antigen-presenting cells. These biochemical interactions reduce pepsin-mediated mucosal irritation and augment localized immune responses, providing therapeutic benefit for hyperacidity and supporting its clinical evaluation in allergen-specific immunotherapies for allergic rhinitis.

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>).