Study design
SAD
SECONDARY, BLIND
This was a prospective, Phase I, double blind, randomized, placebo controlled, dose escalating study conducted at 2 sites. The study comprised 2 parts: Part A included SAD in 8 cohorts (S1 to S8) with a food interaction (FI) arm of 1 cohort and Part B MAD in 5 cohorts (M1 to M5) in which the volunteers were dosed once daily for 7 days after fasting overnight. For all cohorts, sentinel dosing was used, the first 2 participants, 1 active and 1 placebo in each cohort were first dosed and then the remainder of the cohort including 1 placebo were dosed up to 7 days later. Safety and interim plasma PK data were reviewed at safety review committee meetings prior to commencement of the next dose. There were at least 7 days between treatment periods.The primary objective was to determine the safety and tolerability of KCL‐286 administered to healthy adult male subjects in SAD and MAD cohorts, the secondary objective was to determine PK The exploratory objective was to show target engagement of KCL‐286 in MAD cohorts by assessment of RARβ2 expression in WBCs. These data were not used to inform dosing decisions as it was an exploratory biomarker.