What is the Origin of Phase I Clinical Trials?

The concept of phased clinical trials was established by global regulatory agencies, most notably the FDA, following major drug safety crises to ensure a systematic and ethical approach to drug development. Phase I marks the transition from preclinical laboratory research to the first administration of a new compound to human subjects. This systematic approach ensures patient safety is prioritized.

What is the Mechanism of Phase I Clinical Trials?

These trials are usually open-label and non-randomized, focusing on dose escalation studies to identify the Maximum Tolerated Dose (MTD) and characterize the drug's absorption, distribution, metabolism, and excretion (ADME) profile in humans. The mechanism involves intensive monitoring of vital signs, adverse events, and laboratory parameters. For hormonal agents, Phase I data provides the foundational safety and preliminary pharmacokinetic data necessary to guide the design of later efficacy trials.

Phase I Clinical Trials ∞ Area

Phase I Clinical Trials

Meaning

Phase I Clinical Trials represent the initial stage of human testing for a new drug, typically involving a small cohort of healthy volunteers or a limited number of patients with the target condition. The overarching objective of this critical phase is to rigorously assess the drug’s safety profile, determine the maximum tolerated dose, and establish the initial pharmacokinetic parameters in humans. This step is mandatory before moving on to larger efficacy studies.