Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Methodology|Interests|Funding|Corrections
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Defined term · Trial design and conduct

Phase 1

First administration to humans, evaluating safety, tolerability and pharmacokinetics, usually in small numbers and often in healthy volunteers. Efficacy endpoints in a phase 1 study are exploratory…

Document identifier
CEI-GT-060
Series
Defined term
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Phase 1

§1.2Category

Trial design and conduct — Terms describing how a clinical study is constructed and run.

§1.3Related terms

  • Phase 2 — Exploratory clinical development establishing dose and preliminary efficacy. Phase 2 estimates in selected populations are systematically larger than the confirmatory…
  • Exploratory endpoint — An outcome analysed without multiplicity control and without pre-specified inferential status. Hypothesis-generating in every case, including where the result is…
Compound Evidence Institute · CEI-GT-060 · https://compoundevidence.com/glossary/phase-1/ · retrieved 30 July 2026
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