Small-Molecule Neutrophil Modulator ADS051 is Safe and Well-Tolerated in a Phase 1 Single Ascending Dose Study.

ABSTRACT:

Introduction

A need for better treatment options for moderate to severe ulcerative colitis (UC) persists because of the efficacy and safety limitations of current therapies. Neutrophil epithelial transmigration is associated with the characteristic colonic mucosal inflammation in and very likely involved with the pathogenesis and clinical symptoms of UC. ADS051 is a small-molecule inhibiting neutrophil migration and activation, which are potentially important therapeutic targets in UC. The phase 1 single ascending dose study evaluated ADS051's safety, tolerability, and pharmacokinetics in healthy volunteers.

Methods

Fifty healthy adults were randomized 4:1 into 5 ascending dose cohorts to receive a single oral dose of ADS051 100 mg, 300 mg, 700 mg, 1,500 mg, 3,500 mg, or pla

SUBMITTER: Cheifetz AS 

PROVIDER: S-EPMC12208389 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature