This study is the first time in human study and consists of two parts.~Part 1A:~Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.~Part 1B:~Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states~Part 2:~Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.
To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.