LY3000328 Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 890

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Eli Lilly and Company have investigated LY3000328 to evaluate its safety and tolerability in healthy volunteers. These early-stage evaluations incorporated dose-escalation protocols to characterize the compound's preliminary safety parameters. Recruitment for these trials is currently completed, marking the initial phase of clinical assessment for this targeted agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01515358	COMPLETED	Healthy Volunteers	Eli Lilly and Company	2012-02	PHASE1
NCT01515358	Completed	Healthy Volunteers	Eli Lilly and Company	2012-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2012-05-31)

Check the LY3000328 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY3000328 selectively binds to and inhibits the cysteine protease Cathepsin S, thereby blocking downstream major histocompatibility complex class II antigen presentation. By suppressing this proteolytically driven antigen processing in immune cells, the compound attenuates proinflammatory cascades, providing the mechanistic foundation for evaluating its safety and tolerability in Phase 1 trials involving healthy volunteers.

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>).