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).

示例

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

您知道吗？

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).