Safety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from : Design 3+3 Phase I Clinical Trial.

The polyphenol-enriched extract called P2Et derived from had antitumor and immunomodulatory activities reported in breast cancer, leukemia, and melanoma. The aim of this study was to evaluate the safety and maximum tolerated dose of P2Et extract in Colombian healthy volunteers in a phase 1 clinical trial, open labelled, single-arm, dose-escalation design 3 + 3. Seven healthy volunteers were included; P2Et was administrated in capsules of 600 mg/d for 28 days.