What characterizes a phase 1 clinical trial?

A phase 1 clinical trial is characterized by its focus on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug in a small group of healthy human volunteers. The primary goal during this phase is to determine the correct dosing and identify any potential toxicity associated with the drug. Participants in phase 1 trials are typically closely monitored for adverse effects, and the data collected helps researchers to establish safe dosage levels for further studies.

In contrast, the other phases of clinical trials have different objectives. Phase 2 trials aim to evaluate the drug's efficacy and further assess its safety in a larger patient population. Phase 3 trials involve more extensive testing to confirm efficacy and monitor adverse events in diverse, larger groups of patients before seeking approval. Finally, the final approval of a drug by health regulatory agencies occurs only after successful completion of these trials, particularly phase 3, confirming both safety and effectiveness in the intended patient population.