Phase 1 randomized controlled trial

The first of the phases of clinical research.

The first studies conducted in humans using an experimental intervention. These trials often have small sample sizes (e.g., <20), may enroll healthy human participants, and are used to investigate pharmacokinetics, pharmacodynamics, and toxicity.

Phase I trials can be further divided:

Phase 1 A randomized controlled trial

Phase 1 B randomized controlled trial