Phase I studies are the initial stage of clinical trials where the safety and tolerability of a new drug or treatment are evaluated in humans. Researchers focus on determining the maximum tolerated dose (MTD) and identifying any adverse effects of the treatment. The MTD is the highest dose of the treatment that can be given without causing unacceptable side effects. These studies involve a small number of healthy volunteers or patients with the target disease and are carefully monitored to minimize risks. Phase I studies play a crucial role in advancing medical research and improving patient outcomes.
