D-(+)-Trehalose Anhydrous Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A Phase 1 clinical trial, sponsored by Bioblast Pharma Ltd. in collaboration with Parexel, evaluated the safety and tolerability of D-(+)-Trehalose Anhydrous in healthy volunteers. This completed, single-center study used a single ascending dose design to establish the compound's maximum tolerated dose. The investigation provided essential clinical parameters to support future human administration of the agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02725957	Completed	Healthy Volunteer Subjects	Bioblast Pharma Ltd.\|Parexel	2016-03	Phase 1

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

Check the D-(+)-Trehalose Anhydrous product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-reducing disaccharide, D-(+)-Trehalose Anhydrous interacts with biomembranes and native proteins to inhibit conformational unfolding and prevent macromolecular aggregation during environmental or metabolic stress. This cellular preservation effect maintains organelle functionality and reduces physiological stress responses, providing the mechanistic rationale for evaluating its safety and tolerability in healthy volunteer subjects.

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>).