Clinical

Phase 1 Trial

First-in-human safety and pharmacokinetic study, usually 20–80 healthy volunteers.

Definition

Phase 1 trials establish tolerability, dose range, and PK/PD. They typically do not evaluate efficacy. Duration is weeks to months.

Related terms

Phase 2 TrialMid-stage efficacy and dose-ranging study, typically 100–300 patients with the target condition.
Pharmacokinetics (PK)The study of how drugs are absorbed, distributed, metabolized, and excreted.

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