Nastorazepide Clinical Trials

Size	Price	Qty
1mg	USD 129

Clinical Trials

The clinical trial landscape for nastorazepide currently includes a clinical trial dedicated to evaluating the safety profile of this small molecule. Sponsored by Zeria Pharmaceutical, this completed Phase 1 trial in healthy volunteers assessed safety, tolerability, pharmacokinetics, ascending dose responses, and food effects. These foundational findings establish essential safety and pharmacokinetic benchmarks to guide downstream therapeutic evaluations of nastorazepide in patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01776463	Completed	Healthy Volunteers	Zeria Pharmaceutical	2013-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nastorazepide acts as a selective cholecystokinin-2/gastrin (CCK2/gastrin) receptor antagonist that binds the receptor to block downstream gastrin-mediated signaling pathways and downregulate vascular endothelial growth factor (VEGF) expression. This molecular blockade inhibits cell survival and pro-angiogenic activity, providing the mechanistical basis for its initial Phase 1 clinical evaluation in healthy volunteers and its therapeutic potential against pancreatic carcinoma.

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>).