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The design of your first in human study depends on what the objective of the study is

There was no evidence of mutagenic potential when dihydroergotamine mesylate was tested in the presence or absence of metabolic activation in two gene mutation assays (the Ames test and the in vitro mammalian Chinese hamster V79/HGPRT assay) and in an assay for DNA damage (the rat hepatocyte unscheduled DNA synthesis test)

This matters more for injectables than topicals

Although brain metabolism does not significantly contribute to the inter-individual variation in BAC following alcohol ingestion, it is clinically significant due to its acute effects on behavior, reward, and metabolic dyshomeostasis

In a phase II clinical trial, progesterone treatment was given to 77 patients (vs