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Phase I Trials

Meaning

The initial stage of human testing for a new drug or therapeutic agent following extensive preclinical laboratory and animal studies, conducted primarily to assess safety, tolerability, and pharmacokinetics. These trials typically involve a small cohort of healthy volunteers or, in certain contexts like oncology, patients with the target condition, utilizing ascending single or multiple doses. They are a mandatory step in the drug development pipeline, focused on establishing a safe dosage range.