Phase 2 trial
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.
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Related Terms
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.
Phase 3 trialLarge-scale randomized controlled trials (1,000–3,000+ patients) comparing the investigational peptide to placebo or standard of care. Positive Phase 3 results are required for FDA approval.
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.