AZD8797( KAND567) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Novakand Pharma AB has sponsored several Phase 1 and Phase 2 clinical trials evaluating AZD8797 (KAND567) in healthy volunteers, COVID-19 patients, and individuals with gynecologic malignancies, including epithelial ovarian, fallopian tube, and peritoneal cancers. While a Phase 1 safety and pharmacokinetic clinical trial in healthy subjects and a Phase 1/2 clinical trial assessing KAND567 with carboplatin for gynecologic cancers have completed recruitment, a Phase 2 clinical trial in hospitalized COVID-19 patients was initiated but subsequently terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06087289	COMPLETED	Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer	Novakand Pharma AB	2023-04-26	PHASE1; PHASE2
NCT06012565	TERMINATED	Covid19	Novakand Pharma AB	2020-10-11	PHASE2
NCT06030375	COMPLETED	Healthy	Novakand Pharma AB	2020-02-17	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-06-08)

Check the AZD8797( KAND567) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD8797 functions as an allosteric, non-competitive antagonist of the human chemokine receptor CX3CR1, selectively blocking receptor activation to inhibit G-protein signaling and beta-arrestin recruitment, thereby reducing chemokine-driven immune cell recruitment and intracellular inflammatory cascades. By attenuating CX3CR1-mediated leukocyte infiltration and tumor microenvironment signaling, this pathway inhibition serves to reduce hyper-inflammatory pathology in COVID-19 and suppress cancer progression in epithelial ovarian, fallopian tube, and peritoneal malignancies.

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>).