Phase I Clinical Trial

Clinical

First-in-human studies typically enrolling 20-100 healthy volunteers. Primary endpoints are safety, tolerability, PK, and dose range finding. Determines maximum tolerated dose (MTD).

Beispiele

Single ascending dose (SAD)
Multiple ascending dose (MAD)
Food effect studies

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First-in-human studies typically enrolling 20-100 healthy volunteers. Primary endpoints are safety, tolerability, PK, and dose range finding. Determines maximum tolerated dose (MTD).