Human Study definition

Human Study means a clinical program, tested in humans, that has not received permission by the United States Food and Drug Administration under an Investigational New Drug pathway but instead follows the pathway for food development.

Examples of Human Study in a sentence

  • The Company wishes to fund a project entitled, “A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19 (J2W-MC- PYAA)” (ORSP #20-PAF07965) in the Department of Surgery, General Surgery Division under the direction of ▇▇.