Clinical Trials

A completed observational clinical trial sponsored by an academic institution, Università Politecnica delle Marche, investigated 7-Dehydrocholesterol in human subjects without a formal phase classification. The study evaluated mother-fetus relations by assessing the maternal-fetal gradient of free and esterified sterol compounds during term human pregnancy at the time of delivery. Overall, clinical research on 7-Dehydrocholesterol remains specialized, focusing on maternal-fetal lipid transfer dynamics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03705767 Completed
Mother Fetus Relations
Università Politecnica delle Marche
 2016-10-26 --

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

Check the 7-Dehydrocholesterol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

7-Dehydrocholesterol serves as the direct substrate for 7-dehydrocholesterol reductase in the endogenous cholesterol biosynthetic pathway, driving downstream conversion into free cholesterol and photochemical synthesis of vitamin D3 to maintain membrane structure and steroidogenesis. This central involvement in sterol homeostasis underlines its biological relevance in characterizing maternal-fetal lipid transport and metabolic dynamics associated with mother-fetus relations during pregnancy.

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>).

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Note: Technical data last updated: Sep 1, 2026.