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• 14:06, 27 March 2025 Lawrence talk contribs created page First-in-man trials (Created page with "= First-in-man trials = A '''First-in-Man (FIM) trial'''—also known as a '''First-in-Human (FIH) trial'''—is the first clinical study in which a new investigational drug, biologic, or medical device is administered to human participants. These trials follow extensive preclinical testing and are typically classified as Phase 1 trials. The primary focus of FIM trials is to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) before proceeding...")