What is the primary goal of a Phase 1 clinical trial?

The primary goal of a Phase 1 clinical trial is to determine the maximum tolerated dose (MTD) of a new drug or treatment. This phase is crucial in the drug development process, as it typically involves a small number of participants and focuses on assessing safety and tolerability, rather than efficacy or therapeutic outcomes. Researchers aim to establish the highest dose that can be given without causing serious side effects, which helps in understanding the pharmacokinetics and pharmacodynamics of the drug.

In this phase, detailed monitoring is conducted to observe how the drug affects each participant and to identify any adverse reactions. This foundational information is critical for designing subsequent trials, which will later focus on determining effectiveness, comparing treatment options, and assessing patient quality of life. The establishment of the MTD is vital for ensuring participant safety and for the proper dose selection in later phases of clinical testing.