Clinical Trials

A Phase 4 clinical trial sponsored by NYU Langone Health is currently recruiting participants to evaluate BLT-1, focusing on body weight as the primary condition under investigation. The study assesses how weight variations influence physiological and mechanistic outcomes in human subjects. Overall, clinical research for BLT-1 remains centered on academic investigation into physiological factors related to body weight.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04697719 Recruiting
Body Weight
NYU Langone Health
2021-11-04 Phase 4

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

Check the BLT-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BLT-1 acts as a thiosemicarbazone copper chelator that selectively inhibits the high-density lipoprotein (HDL) receptor scavenger receptor class B member 1 (SR-BI), thereby blocking SR-BI-mediated lipid transfer between HDL particles and cellular membranes. By disrupting cellular lipid uptake and modulating systemic lipid transport, this target inhibition impacts metabolic lipid processing relevant to clinical studies investigating body weight management and energy homeostasis.

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.