Clinical Trials

A clinical trial sponsored by an academic institution, the Tulane University School of Social Work, has completed recruitment without an assigned clinical phase to evaluate the intervention program. The study targeted observational and behavioral conditions, focusing on adolescent behavior, risk reduction, and psychological stress to mitigate health risks and support emotional well-being. Overall, this research underscores an emphasis on behavioral health interventions rather than traditional therapeutic drug development.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02386878 COMPLETED
Adolescent Behavior; Risk Reduction Behavior; Stress, Psychological
Tulane University School of Social Work
2012-01

(data from https://clinicaltrials.gov, updated on 2017-03-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isopropyl β-D-thiogalactoside functions as a non-metabolizable molecular mimic of allolactose that binds directly to the lac repressor protein, inducing a conformational change that prevents operator binding and derepresses gene transcription to stimulate protein expression. While this biochemical mechanism primarily drives recombinant protein synthesis in laboratory settings, clinical evaluations linked to this entry focus on behavioral interventions targeting adolescent behavior, risk reduction behavior, and psychological stress.

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>).

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