Pharmacokinetics and safety of a single dose of the novel necrosis inhibitor LC28-0126 in healthy male subjects.

ABSTRACT:

Aims

A novel necrosis inhibitor, LC28-0126, is expected to have a cellular protective effect from ischaemic reperfusion injury in acute myocardial infarction. The objective of this study was to investigate the safety, tolerability and pharmacokinetics of LC28-0126 after a single intravenous administration in healthy male subjects.

Methods

The study was a dose-block-randomized, double-blind, placebo-controlled, single ascending dose, first-in-human trial. Subjects were randomly assigned to receive 0.3, 1, 3, 10, 25, 50, 100 or 200 mg of LC28-0126. LC28-0126 was infused for 30 min and 5 min in cohorts 1 and 2, respectively. An interim analysis to assess the tolerability and pharmacokinetics was conducted in each dose group. Blood samples were taken to determine plasma LC28-012

SUBMITTER: Kim S 

PROVIDER: S-EPMC5427235 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature