This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects and to perform a preliminary assessment of the effect of food on safety and PK parameters of J147. The study will include single ascending dose (SAD) in healthy young and elderly subjects.~Approximately 64 subjects may be included in the study, with an additional 24 to be added depending on the emerging data.~Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and female subjects are planned. Depending on emerging safety, tolerability and PK data, 2 additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of 8 elderly male and female subjects may be enrolled.~In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2 subjects will be randomized to receive a matching dose of placebo.~All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1 subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours following the sentinel subjects.~Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects.