July 16, 2018
BELLUS Health announced the initiation of healthy subjects dosing in a Phase I clinical study for BLU-5937, its lead drug candidate for the treatment of chronic cough. The main objectives of the Phase I clinical study are to assess the safety, tolerability (including taste perception) and pharmacokinetic profile of BLU-5937 in healthy subjects. This is a randomized, double-blind, placebo-controlled study of orally administered BLU-5937 in up to 90 healthy adult subjects. The study will be divided in two parts. Part 1: A single-ascending dose (“SAD”) study will be conducted in up to 60 healthy subjects. Subjects will be randomized into up to 6 cohorts of 10 subjects (8 BLU-5937: 2 placebo). Part 2: A multiple-ascending dose (“MAD”) study will be conducted in up to 30 healthy subjects. Subjects will be randomized into up to 3 cohorts of 10 subjects (8 BLU-5937: 2 placebo). Each subject will receive daily oral administrations of the assigned treatment for seven consecutive days. The dose regimen for the MAD study will be established based on the SAD study results.