Randomized, double-blind, placebo-controlled Phase I study in healthy individuals on autotaxin-inhibition with MJK2134025 in single-ascending, as well as multiple intravenous doses

Corrective measure CM-DE-0001

Member state

Germany

Publication date

2025-10-22

Type

3

Reason

4

Reverted date

2025-10-22

Immediate action required

Yes

Notes

Reverted (2025-10-22)

Justification

We have received the message from our Belgian colleagues that the facility of the Chinese CRO Shanghai Institute of Materia Medica (SIMM), was removed from the Belgian monitoring programme. Several major deviations at the last periodic inspection were observed. Since a GLP inspection is a retrospective assessment, no studies since last successful GLP inspection in October 2022 can be considered as OECD-GLP compliant based on all observed deviations. That means that Belgium does not support any claim of compliance made to all studies since last inspection, October 2022. As indicated in the NIC, no study since then should be considered as GLP compliant based on all observed non compliances in their general quality management system and management of GLP studies, that includes toxicity, safety pharmacology and genotoxicty studies. No claim of GLP on studies done since October 2022 should be considered OECD-GLP compliant based on a GLP certificate granted by Sciensano after the last inspection in 2022. As indicated in the documentation for application of the above mentioned clinical trial, all relevant pivotal GLP studies were conducted after October 2022, therefore, these studies cannot be considered as OECD-GLP compliant anymore. Due to this fact, the safety of the healthy subjects in the first in human study cannot be guaranteed at the moment.

As the toxicology studies, which are pivotal for the approval of the clinical trial, are now considered as non-GLP studies, you are asked to stop the clinical trial immediately.