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Phase 1 trial

First-in-human safety trial. Small (20-80) and not designed to prove benefit.

Phase 1 trials test safety and dose tolerability in healthy volunteers (or sometimes patients). Small (typically 20-80 people), short duration, not designed to prove the drug works — just to establish that humans tolerate it and to find pharmacokinetics (absorption, half-life, clearance). Most off-label peptides have only phase 1 data, which is why community doses are often extrapolated rather than evidence-based.