Vinhedo

Researchers are evaluating the safety, tolerability, and pharmacokinetics of Extrato de Cannabis sativa GreenCare 79.14 mg/mL in healthy adults aged 18 to 65 years. This Phase I clinical trial aims to determine whether this cannabis extract solution is safe for use and to identify the maximum tolerated dose (MTD). Participants will be healthy individuals with normal lab results or clinically insignificant deviations. The study involves two stages. In Stage 1, about 60 participants will receive a single dose of the cannabis extract solution after breakfast, with doses ranging from 39.62 mg to 791.4 mg, to find the maximum tolerated dose. In Stage 2, 12 participants will receive the determined MTD in two daily doses for 14 consecutive days. The extract is delivered as a solution diluted in MCT oil. During the study, participants will be monitored for safety and pharmacokinetic measurements. Researchers will assess tolerability and any side effects. The main outcome is identifying the MTD within 5 days. Participants must comply with diet requirements and study procedures. The total participation period includes screening, dosing stages, and safety assessments to ensure proper monitoring throughout.