A randomized phase I study of the safety and pharmacokinetics of BI 1291583 in healthy Japanese male subjects.

ABSTRACT:

Aims

Bronchiectasis patients face an unmet need for treatment options that reduce inflammation. Cathepsin C inhibition is expected to achieve this by reducing the activation of neutrophil-derived serine proteases. Here, we present safety and pharmacokinetic (PK) data from a Phase I trial evaluating the novel cathepsin C inhibitor BI 1291583 in healthy Japanese male subjects.

Methods

This randomized, double-blind, placebo-controlled, parallel-group study investigated BI 1291583 in healthy Japanese male subjects (jRCT2071210111) and consisted of a single-rising-dose (SRD) part and a multiple-dose (MD) part. The primary endpoint was the percentage of subjects with drug-related treatment-emergent adverse events (AEs). Secondary PK endpoints (SRD: AUC_0-∞ and C_max<

SUBMITTER: Tadayasu Y 

PROVIDER: S-EPMC11671317 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature