Phase 1 trial
The first stage of human clinical testing, focused on safety, tolerability, pharmacokinetics, and dose-ranging in 20–100 healthy volunteers. Determines the maximum tolerated dose.
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Related Terms
The clinical trial stage that evaluates efficacy, optimal dosing, and side effects in 100–300 patients with the target condition. Phase 2 results determine whether to proceed to large Phase 3 trials.
Clinical trial phasesThe staged process of testing a new drug in humans: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale confirmation), and Phase 4 (post-marketing surveillance). Each phase has specific objectives and requirements.
Maximum tolerated doseThe highest dose of a peptide that can be administered without causing unacceptable side effects. Determined in Phase 1 clinical trials through dose-escalation studies.
PharmacokineticsThe study of how the body absorbs, distributes, metabolizes, and excretes a peptide over time (what the body does to the drug). Described by parameters including Cmax, Tmax, AUC, half-life, and clearance.