A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults.

ABSTRACT: GLH8NDE, a derivative of eupatilin, is currently under development to treat dry eye disease. We conducted a randomized, double-masked, placebo-controlled, single- and multiple-day study to evaluate safety, tolerability, pharmacodynamics, and pharmacokinetics of ocular GLH8NDE in healthy male adults. Subjects randomly received topical ocular dosing of GLH8NDE or its matching placebo for a day, then for 7 consecutive days with a 62-h washout at one of the following daily doses: 9, 18, 36 (Koreans), and 36 mg (Whites). The study drug was administered in divided doses over 10 h with 2- or 5-h intervals. Thirty-nine (97.5%) out of 40 subjects completed the study. A total of 17 subjects experienced 31 treatment-emergent adverse events, all of which were mild in severity and recovered without seq

SUBMITTER: Jung J 

PROVIDER: S-EPMC8841454 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature