Safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of vutiglabridin: A first-in-class, first-in-human study.

ABSTRACT: This study aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of vutiglabridin, a potential anti-obesity treatment under development, for the first time in humans. A randomized, placebo-controlled, single- and multiple-ascending dose study (SAD and MAD, respectively) was performed in healthy Koreans and Whites. Subjects randomly received a single oral dose of 30-720 mg vutiglabridin or placebo at a ratio of 8:2 in the SAD study or 240-480 mg vutiglabridin or placebo once daily for 14 days in the MAD study. Food effect was also evaluated in 240 mg single dose group. Pharmacokinetics were evaluated through plasma concentrations, and pharmacodynamic biomarkers related to obesity or inflammation were analyzed. Safety and tolerability were assessed throughout the

SUBMITTER: Na JY 

PROVIDER: S-EPMC9652434 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature