DDD107498 Clinical Trials

Size	Price	Qty
5mg	USD 417
25mg	USD 1,259

Clinical Trials

A clinical trial sponsored by Merck KGaA, Darmstadt, Germany, has completed evaluating the novel antimalarial agent DDD107498 (also known as M5717). Conducted as a first-in-human Phase 1 study, it evaluated single and multiple ascending oral doses in healthy volunteers to assess safety, tolerability, and pharmacokinetic parameters. These preliminary results establish essential human safety profiles to support the further clinical development of the compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03261401	Completed	Healthy	Merck KGaA Darmstadt Germany	2017-09-15	Phase 1

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

Check the DDD107498 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DDD107498 selectively binds to Plasmodium falciparum translation elongation factor 2, thereby halting ribosomal translocation and suppressing parasite protein synthesis. This potent inhibition disrupts protein translation across multiple life-cycle stages of the parasite, providing the biological foundation for testing its safety, tolerability, and pharmacokinetics in healthy volunteers during early-phase clinical trials.

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>).