One of the most significant events in the modern history of drug development was the first regulatory approval in the 1990s of an entirely new class of drugs called protein kinase inhibitors. Protein kinases are regulatory proteins inside cells that maintain homeostasis and whose dysregulation can cause disease. Novel small molecules that can selectively bind to certain protein kinases can stop disease progression. Cancer was the first disease indication for approval of a protein kinase inhibitor drug, and it continues as the major disease area for regulatory approval. There is a void in approved protein kinase inhibitor drugs for neurodegenerative and neuropsychiatric diseases in spite of a growing body of supportive research and clinical data. We, therefore, developed a platform for the discovery and preclinical development of potential brain kinase inhibitor drug candidates for potential use in central nervous system disorders. We recently described a promising candidate, called MW150, for future clinical development in diseases where the targeted kinase is a contributor to disease susceptibility or progression such as Alzheimer's disease and related neurodegenerative disorders. However, final stages of preclinical development require toxicity testing following FDA guidelines in order to define any potential safety issues for novel small molecules, called new chemical entities, before first-in-human studies can begin. The studies proposed here are a highly focused set of investigations by an independent FDA-certified contract research company, with anticipated safety parameters being used as one part of an investigational new drug (IND) filing to allow safety testing in volunteers. Overall, MW150 represents a unique protein kinase inhibitor and a viable candidate for future drug development relevant to synaptic dysfunction associated within the broad area of dementia and neurodegeneration. Successful completion of the array of IND-enabling research investigations, including the definitive preclinical toxicity studies proposed here, will allow future first-in-human clinical studies.