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Phase 1 Trial

Meaning

The initial stage of clinical research for a new drug, hormone, or therapeutic agent, typically conducted in a small group of human volunteers, who are often healthy or sometimes have the condition of interest. The primary and overriding objectives of this trial phase are to evaluate the compound’s fundamental safety profile, determine a safe and tolerable dosage range, and study its basic pharmacokinetics and pharmacodynamics. This phase is not primarily designed to assess efficacy but rather to establish fundamental human tolerance and biological activity. Successfully completing this trial is an essential prerequisite for advancing to larger-scale efficacy studies.