When planning a first in human (FIH) trial, a carefully tailored design is mandatory for safety and further decision making.

The design should not be based on the minimum regulatory requirements, or even just “good habits,” but on bespoke scientific rationale.

Depending on the pharmacological and safety profile of the drug, broader pre-clinical data may be needed than those required by regulators to ensure not only safety but also to increase the potential success of the development.

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