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Using the safety and feasibility data from these first-in-human trials demonstrating that intermittent D+Q was well tolerated in 50 subjects (NCT 02874989 and NCT 02848131), combined with the efficacy data in mouse models, we initiated a Phase I study of senolytic therapy in older adults with early-stage symptomatic AD, SToMP-AD (Senolytic Therapy to Modulate the Progression of Alzheimers Disease, NCT04063124) (107)

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21 CFR 211.84 FDA cited 21 CFR 211.84 (failure to test and approve or reject components, drug product containers, and closures) a total of 37 times