DURECT Corporation announced it has initiated a single-ascending-dose Phase 1b clinical trial with DUR-928 in patients with nonalcoholic steatohepatitis (NASH). DUR-928 is an endogenous, small-molecule, new chemical entity (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and NASH, and in acute organ injuries such as acute kidney injury (AKI). This Phase 1b trial of DUR-928 is a dose ranging, single-ascending-dose safety and pharmacokinetic study of DUR-928 of subjects with NASH and matched control subjects.

This study will be conducted in three successive cohorts evaluating three single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to a successively higher dose. Assuming all three cohorts are dosed, the study will comprise approximately 48 subjects, of which approximately 30 will have received DUR-928.

The study is being conducted in Australia and anticipate that it will be completed in the first half of 2016.