Phase 1 trials commonly use dose-escalation designs (e.g., 3+3, BOIN) and enroll healthy volunteers or, for oncology, patients with advanced disease.
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Glossary Term
Phase 1 Trial
Study Design
Also known as: Phase I, first-in-human, FIH study
An early-phase clinical study, usually first-in-human, that evaluates safety, tolerability, and pharmacokinetics in a small group of subjects.
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