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Phase 1 Safety Trials

Meaning

Phase 1 Safety Trials represent the initial stage of human testing for a new drug, vaccine, or medical intervention following extensive pre-clinical development. The primary objective of this phase is to evaluate the treatment’s safety profile, determine the maximum tolerated dose (MTD), and understand its pharmacokinetics and pharmacodynamics in humans. These trials typically involve a small cohort of 20 to 100 participants, often healthy volunteers, though they may include patients with advanced disease for high-risk therapies. This stage is absolutely critical as it provides the first data on how the compound interacts with the human body.