The provided text discusses the safety and tolerability profile of the compound CMS121, drawing information from preclinical animal studies and a completed Phase I clinical trial in healthy human subjects.
Animal studies indicated no significant adverse effects, even demonstrating benefits like increased lifespan in some models and good toleration in disease models without organ toxicity.
The Phase I trial further supported its safety, showing that oral administration of CMS121, even at high doses, was generally well-tolerated, with most side effects being mild and transient, primarily gastrointestinal issues or headaches. Importantly, no significant abnormalities were found in laboratory tests related to liver, kidney, or blood function, nor in cardiac parameters.
The text also notes favorable pharmacokinetics, including increased concentration in older individuals and improved bioavailability with food, ultimately concluding that CMS121 exhibits an encouraging safety profile at this stage of development.
