CONNECTA Therapeutics begins administration of CTH120 to the first healthy volunteers in Phase I clinical trial
Hospital del Mar Research Institute
CONNECTA Therapeutics announces that the first healthy volunteers in the Phase I clinical trial of CTH120 have been administered the drug at Hospital del Mar – Hospital del Mar Research Institute in Barcelona. The study is recruiting 68 healthy individuals, both women and men aged between 18 and 55 years, with the aim of confirming the safety and tolerability of CTH120 for the treatment of Fragile X syndrome (FXS) and other neurodevelopmental disorders.
The trial is authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) and is being conducted following a protocol approved by the Drug Research Ethical Committee of Hospital del Mar.
The study is led by Dr Rafael de la Torre, Coordinator of the Integrated Pharmacology and Systems Neuroscience Research Group at the Hospital del Mar Research Institute, and Dr Ana Aldea, Coordinator of the Hospital del Mar Research Institute Clinical Research Unit and Head of the Clinical Pharmacology Section at Hospital del Mar.
“The Phase I clinical trial, with an estimated duration of one year, is a randomised, double-blind, placebo-controlled study and consists of three parts: single ascending doses, multiple ascending doses and food interaction. The results are expected in the second quarter of 2024 and will allow us to confirm the CTH120 drug’s safety profile and to evaluate its efficacy in patients in future clinical trials,” explains Dr Josep Prous, Chief Scientific Officer at CONNECTA Therapeutics.
More information: https://connectatherapeutics.com/clinical-trials/